Early tracheostomy in critically ill patientsHossam atef
This meta-analysis reviewed 14 randomized controlled trials comparing early tracheostomy (within 10 days of mechanical ventilation) to prolonged intubation in critically ill patients. The analysis found:
1) Early tracheostomy did not reduce mortality, duration of mechanical ventilation, ICU stay, or incidence of ventilator-associated pneumonia compared to prolonged intubation.
2) It did reduce the duration of sedation use but did not decrease the duration of mechanical ventilation.
3) Significantly more tracheostomy procedures were performed in the early tracheostomy group.
The study concludes that early tracheostomy before 10 days does not provide benefits and may lead to unnecessary procedures, so its routine use is not recommended. Further research
This document summarizes a longitudinal study that assessed the long-term health-related quality of life (HRQoL) of liver transplant recipients in Southwest China using the Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire. The study found that while liver transplant recipients initially had significantly worse HRQoL scores than the general population, their scores improved in subsequent years after transplantation. Patients who lived more than 10 years after transplantation demonstrated significant improvements in health status and high mental health scores, indicating improved psychological conditions over time.
UK based multicentric trial involving 364 critically ill patients who were deemed difficult to wean, was conducted to prove shorter time to liberation from mechanical ventilation with non invasive weaning compared to invasive weaning.
This study evaluated the effects of atorvastatin for treating asthma patients through a double-blind randomized clinical trial. 62 patients with mild to moderate persistent asthma were alternately allocated to receive either atorvastatin or a placebo for 8 weeks. Asthma control was assessed before and after treatment using the Asthma Control Test questionnaire. The study found no significant differences in asthma control between the atorvastatin and placebo groups, indicating that atorvastatin was not effective for treating mild to moderate asthma over the study period based on the measures used. The summary discusses some limitations of the study related to sensitivity of outcome measures and potential bias from the alternating allocation method used.
This study reviewed 7 previous studies to investigate whether a 90 minute door-to-balloon time (DTB) metric improves outcomes for STEMI patients undergoing percutaneous coronary intervention (PCI). The results of the studies were mixed, with some showing decreased mortality for shorter DTB times below 2 hours, while others found no significant change in mortality even as DTB times decreased. The authors concluded that while DTB is important and any treatment delay can increase mortality, it is not the sole determining factor and total ischemic time must also be considered. Efforts to improve outcomes should focus on decreasing time from symptom onset to hospital presentation as well as time to treatment.
This document outlines a protocol for conducting a therapeutic drug monitoring study, including sections for the title, investigators, study location, patient recruitment details, need for the study, objectives, patient selection criteria, procedures for blood sample collection and storage, instruments for measuring drug and clinical levels, report preparation, clinical interpretation, and conclusion.
Early tracheostomy in critically ill patientsHossam atef
This meta-analysis reviewed 14 randomized controlled trials comparing early tracheostomy (within 10 days of mechanical ventilation) to prolonged intubation in critically ill patients. The analysis found:
1) Early tracheostomy did not reduce mortality, duration of mechanical ventilation, ICU stay, or incidence of ventilator-associated pneumonia compared to prolonged intubation.
2) It did reduce the duration of sedation use but did not decrease the duration of mechanical ventilation.
3) Significantly more tracheostomy procedures were performed in the early tracheostomy group.
The study concludes that early tracheostomy before 10 days does not provide benefits and may lead to unnecessary procedures, so its routine use is not recommended. Further research
This document summarizes a longitudinal study that assessed the long-term health-related quality of life (HRQoL) of liver transplant recipients in Southwest China using the Medical Outcomes Study Short Form 36 (MOS SF-36) questionnaire. The study found that while liver transplant recipients initially had significantly worse HRQoL scores than the general population, their scores improved in subsequent years after transplantation. Patients who lived more than 10 years after transplantation demonstrated significant improvements in health status and high mental health scores, indicating improved psychological conditions over time.
UK based multicentric trial involving 364 critically ill patients who were deemed difficult to wean, was conducted to prove shorter time to liberation from mechanical ventilation with non invasive weaning compared to invasive weaning.
This study evaluated the effects of atorvastatin for treating asthma patients through a double-blind randomized clinical trial. 62 patients with mild to moderate persistent asthma were alternately allocated to receive either atorvastatin or a placebo for 8 weeks. Asthma control was assessed before and after treatment using the Asthma Control Test questionnaire. The study found no significant differences in asthma control between the atorvastatin and placebo groups, indicating that atorvastatin was not effective for treating mild to moderate asthma over the study period based on the measures used. The summary discusses some limitations of the study related to sensitivity of outcome measures and potential bias from the alternating allocation method used.
This study reviewed 7 previous studies to investigate whether a 90 minute door-to-balloon time (DTB) metric improves outcomes for STEMI patients undergoing percutaneous coronary intervention (PCI). The results of the studies were mixed, with some showing decreased mortality for shorter DTB times below 2 hours, while others found no significant change in mortality even as DTB times decreased. The authors concluded that while DTB is important and any treatment delay can increase mortality, it is not the sole determining factor and total ischemic time must also be considered. Efforts to improve outcomes should focus on decreasing time from symptom onset to hospital presentation as well as time to treatment.
This document outlines a protocol for conducting a therapeutic drug monitoring study, including sections for the title, investigators, study location, patient recruitment details, need for the study, objectives, patient selection criteria, procedures for blood sample collection and storage, instruments for measuring drug and clinical levels, report preparation, clinical interpretation, and conclusion.
This study examined the associations between dietary fat intake and mortality in two large cohorts over several decades. Higher intakes of polyunsaturated fatty acids (PUFAs) and monounsaturated fatty acids (MUFAs) were associated with lower mortality, while higher intakes of saturated fatty acids (SFAs) and trans fatty acids (TFAs) were associated with higher mortality. Replacing SFAs with PUFAs or MUFAs was associated with lower risks of total and cause-specific mortality, including from cardiovascular disease, cancer, and neurodegenerative diseases.
This study compared outcomes of a pharmacoinvasive strategy (tenecteplase fibrinolysis followed by early angiogram and PCI if needed) versus primary PCI in Indian patients with STEMI over 2 years. The pharmacoinvasive strategy resulted in similar outcomes to primary PCI at 2-year follow-up, with no differences in the composite primary endpoint of death, shock, reinfarction, revascularization or heart failure. Initially, primary PCI seemed more beneficial but by 2 years the groups were similar, suggesting fibrinolysis followed by angiogram is a reasonable alternative when PCI is not immediately available. The pharmacoinvasive strategy had benefits like less thrombus burden and higher rates of open arteries. This supports adopting such a strategy where delays
Quality of life (qol) among university students in jordan a descriptive studyAlexander Decker
This study examined quality of life (QOL) among 119 nursing students in Jordan using the Medical Outcomes Study Short Form 36 (SF-36). The highest domain score was for physical functioning (78.1) and the lowest was for vitality (52.3). Males scored significantly higher than females on physical functioning. Employed students scored significantly lower than unemployed students on role physical, social functioning, and bodily pain domains. No other demographic factors like clinical course enrollment or GPA were significantly associated with QOL domain scores. This provides preliminary information about nursing student QOL in Jordan.
This document provides details about an upcoming clinical trial course on design, analysis, interpretation and reporting of clinical trials. It includes information about the course faculties from McMaster University and Christian Medical College, Vellore. The 5-day course will cover topics like types of clinical trials, CONSORT guidelines, design considerations, systematic reviews, meta-analysis, statistical analysis methods, sample size calculation and preparing FDA submissions. One of the clinical trials described is about assessing the effect of a preoperative short-term structured exercise program on postoperative quality of recovery in patients undergoing major abdominal cancer surgeries.
Virtual Reality Reflection Therapy Improves Balance and Gait in Patients with...Avi Dey
Technology enhanced version of Mirror Box Therapy called Virtual reality reflection therapy (VRRT) . Taesung In Et Al, (Department of Physical Therapy, College of Health Science, Sahmyook University, Seoul, South Korea) . Referred by Café Twin, Fairfax, VA USA. (LinkedIn.com/Café Twin) 2016
Aderenta la tratamentul inhalator in bolile respiratoriiTraian Mihaescu
The document discusses adherence to inhaler treatment for conditions like asthma and COPD. It begins by explaining how reward circuitry in the brain reinforces behaviors that promote survival. It then defines adherence and compliance, noting that adherence involves active patient participation while compliance is more passive following of doctor's orders. The document outlines factors influencing adherence like treatment complexity and social support. It reviews data showing poor adherence to inhalers and notes lower adherence for pulmonary diseases. Finally, it discusses the importance of patient education and inhaler type on adherence, emphasizing the need for simple, effective treatment plans to improve outcomes.
A randomized, double-blind, placebo-controlled pilot study was conducted to determine if preoperative modafinil improved recovery after general anesthesia in patients with obstructive sleep apnea (OSA). 102 patients with OSA were given either 200mg of modafinil or placebo before surgery. The primary outcome of length of stay in the post-anesthesia care unit (PACU) showed no difference between groups. Secondary measures of emergence and recovery also did not differ significantly. While respiratory rate was higher and blood pressure lower in the modafinil group in the PACU, the study results suggest single-dose preoperative modafinil does not improve functional recovery after general anesthesia in patients with OSA.
This document outlines a proposed study on the efficacy of intravenous lidocaine in preventing fentanyl-induced cough before induction of anesthesia. The study aims to determine if lidocaine reduces the incidence of cough caused by fentanyl injection before anesthesia by 30% compared to placebo. It will involve 96 patients randomized to receive either lidocaine or saline before fentanyl injection. The primary outcome is reduction in cough incidence and secondary outcomes include hemodynamic stability and adverse effects. The proposed methodology describes patient selection criteria, interventions, data collection and analysis in detail.
Dr. Ashutosh Soni has over 15 years of experience in nephrology. He completed his DM in nephrology from Banaras Hindu University in 2011. Since then, he has worked as assistant professor, head of department, and consultant nephrologist at various hospitals in India. Currently, he works as head of nephrology at Monilek Hospital in Jaipur, which has performed over 600 kidney transplants. His clinical expertise includes renal transplantation, dialysis, and management of kidney diseases.
This document presents a research synopsis on assessing the knowledge of renal diet among primary caregivers of renal failure patients. The study aims to evaluate the existing knowledge of primary caregivers regarding renal diet using a questionnaire and to develop a self-instructional module on renal diet. It will recruit 60 primary caregiver samples using non-probability purposive sampling from selected hospitals. Data will be collected using a demographic section and knowledge assessment questionnaire, and analyzed using frequency, percentage, mean and chi-square tests. Findings will be disseminated through publications and workshops.
Ethical and Participant Safety considerations in Clinical TrialsKunal Sampat
This document discusses key ethical considerations for clinical trial protocols and conduct. It outlines standard protocol elements such as format, content, and administrative responsibilities. Some important ethical considerations in protocol development include appropriate inclusion/exclusion criteria, choice of efficacy and safety parameters, and procedures for handling medical emergencies and early trial discontinuation. When conducting trials, important ethical areas are recruiting and screening patients, maintaining confidentiality of data, and following the Declaration of Helsinki for protecting human subjects.
Effect of food on pharmacokinetics of meloxicam ijsit 2.3.7IJSIT Editor
The primary objective of the study was to investigate the effect of food on the pharmacokinetics of
MELOXICAM. Cmax, Tmax and AUC of MELOXICAM were defined as the main parameters for the assessment
of bioavailability and bioequivalence of MELOXICAM administered in fasting and fed conditions. The 90% CI
for the fed/fasting MELOXICAM did not contained within the acceptance interval (80, 125) and, therefore, it
can be concluded that the rate of systemic exposure to MELOXICAM does not fit the claim of bioequivalence
between administration in fasting and fed conditions. This study has demonstrated that all the
pharmacokinetic parameters of both the treatments were statistically different from each other. In the fed
condition the values of Cmax and AUC were decreased while Tmax increases than that of fasting which
demonstrated that the extent of systemic exposure to MELOXICAM was affected by the delay in absorption of
MELOXICAM in the presence of food. None of the study volunteers reported any serious adverse effects
throughout the study. The only two AEs reported were mild and not related to the study medication. The AEs
reported were, according to the study medical expert, related to the sampling procedure and were self
limiting and did not require any treatment. There was no change in the vital signs of the volunteers
throughout the study period. The presented data are of major importance in identifying the optimal dosing
regimen for future clinical trials with oral MELOXICAM. In our study, only one type of food (a standardized
continental breakfast) was evaluated; further studies are needed to assess the effects of foods with different
compositions and contents on the bioavailability of MELOXICAM.
Curriculum Vitae Dr Harsh Vardhan for Consultant 24June2016Harsh Vardhan
Dr. Harsh Vardhan has over 28 years of experience as an anesthesiologist. He has worked in both military and civilian hospitals, providing anesthesia for a wide range of surgical specialties. He has held leadership roles including head of department and professor. Currently he works as a consultant anesthesiologist in Bahrain, where he provides care for general surgery, OB/GYN, orthopedics and other specialties.
Seminar first semester Simvastation in COPDSwty Sweta
This document summarizes a study that investigated whether simvastatin could prevent exacerbations in patients with moderate to severe COPD. The study involved 885 patients randomized to receive either simvastatin 40mg daily or a placebo. The primary outcome was the exacerbation rate, and secondary outcomes included time to first exacerbation, lung function, quality of life, and adverse events. The results showed no significant differences between the simvastatin and placebo groups in exacerbation rate, time to first exacerbation, or secondary outcomes. Simvastatin 40mg daily did not demonstrate a therapeutic benefit for reducing exacerbations in patients with moderate to severe COPD.
Effect of Four -Weeks Yogic Training Program on Selected Hematological Parame...Sports Journal
The aim of present study was to know the Effect of four - weeks yogic training program on selected Hematological parameters among male students. The training was conducted in the morning session of one hour for the period of four- weeks. The study was conducted on higher secondary school level male students. Total ten male students were be selected as subject. These subjects were selected in terms of purposive samples from the 8th, 9th, 10th, 11th and 12th standards from Senior Secondary Model School Punjabi University Patiala. Two Hematological variables namely Erythrocytes and Leucocytes were selected for the purpose of this research. The results of the study reveals that there was significant effect of four weeks yogic protocol on erythrocytes and leucocytes count among male students.
Effect of Emergency Department and ICU Occupancy on Admission Decisions and O...Ching-wen Lu
1) Critically ill patients requesting admission to a busy medical ICU (MICU) had lower odds of acceptance when the MICU was at full capacity, despite availability in other ICUs.
2) For patients both accepted and denied MICU admission, longer boarding times in the emergency department post-consult were associated with higher risk of in-hospital mortality or persistent organ dysfunction.
3) The study highlights the impact of ICU bed availability and emergency department crowding on decisions to admit critically ill patients, and shows that increased boarding time is an independent risk factor for worse patient outcomes.
The document provides an overview of different departments and functions within a hospital pharmacy. It discusses departments like the dispensary, pathology, surgical ward, emergency department and waste management. It also covers various medical tests performed in pathology like the Widal test for typhoid, pregnancy test, and blood glucose test. Common drugs and injections available in the dispensary are also outlined, including those used for pain relief, antibiotics, and allergies. Different routes of drug administration such as oral, intramuscular, intravenous and more are also reviewed.
This document provides definitions for various clinical trial terms. It defines terms like adverse reaction, approval, arm, baseline, bias, blinding, case control study, clinical, clinical investigator, clinical research associate, and many others. For each term there is a brief 1-2 sentence definition explaining the meaning in the context of clinical research.
Background: Optimum learning environments (LEs) are linked with positive training outcomes for residents. However, there is few data concerning how the residents perceive the learning environments in teaching hospitals. This study aims to analyze the residents’ perceptions of their learning environments.
Methods: This cross-sectional, hospital-based study was carried out between November 2020 and January 2021, using a Postgraduate Hospital Educational Environment Measurement (PHEEM) questionnaire. Statistical analysis was conducted using SPSS 20.
Results: The total number was 45 participants, 40 of them successfully responded. The total Cronbach`s alpha score was 0.93, which reflects good reliability. The full-scale score was 128 out of 160, which indicates a good learning environment. The autonomy score was 44, the teachers' score was 50, and social support was 34. Finally, the overall mean score for females was 43.3 compared to 39.4 for males, with a P-value of 0.55. Furthermore, no significant difference in residents’ perceptions of their learning environment according to their training was observed in this study.
Conclusion: Significant challenges in the LE were identified; more attention and effort should be given, especially to the poorly rated point in this study: the existence of an informative program, clear clinical protocols, and proper setting expectations. The lowest score was for catering, housing. A high social support score indicates a healthy workplace environment and job satisfaction.
A study conducted at Children's Hospital of Philadelphia over 7 years involving over 4,400 pediatric catheterization procedures found that operator-directed sedation, where a nurse sedates patients under the supervision of an interventional cardiologist, resulted in fewer adverse events, shorter procedure times, and quicker exit times compared to general anesthesia. However, the study also noted that cardiac anesthesiologists are still important for complex or urgent cases given their specialized expertise.
Dexamethasone trial in chronic subdural hematomaSandesh Dahal
This document summarizes a journal club presentation on a randomized controlled trial investigating the use of dexamethasone for chronic subdural hematoma. The trial found that patients receiving dexamethasone had a less favorable functional outcome at 6 months compared to placebo, as measured by the modified Rankin scale. Secondary outcomes also showed higher rates of adverse events in the dexamethasone group. The results do not support the use of dexamethasone for chronic subdural hematoma as it may be associated with harm.
A Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and ...DeepaKarn
A Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Forskolin Eye Drops 1% in the Treatment of Open AngleGlaucoma – A Comparative Study
This study examined the associations between dietary fat intake and mortality in two large cohorts over several decades. Higher intakes of polyunsaturated fatty acids (PUFAs) and monounsaturated fatty acids (MUFAs) were associated with lower mortality, while higher intakes of saturated fatty acids (SFAs) and trans fatty acids (TFAs) were associated with higher mortality. Replacing SFAs with PUFAs or MUFAs was associated with lower risks of total and cause-specific mortality, including from cardiovascular disease, cancer, and neurodegenerative diseases.
This study compared outcomes of a pharmacoinvasive strategy (tenecteplase fibrinolysis followed by early angiogram and PCI if needed) versus primary PCI in Indian patients with STEMI over 2 years. The pharmacoinvasive strategy resulted in similar outcomes to primary PCI at 2-year follow-up, with no differences in the composite primary endpoint of death, shock, reinfarction, revascularization or heart failure. Initially, primary PCI seemed more beneficial but by 2 years the groups were similar, suggesting fibrinolysis followed by angiogram is a reasonable alternative when PCI is not immediately available. The pharmacoinvasive strategy had benefits like less thrombus burden and higher rates of open arteries. This supports adopting such a strategy where delays
Quality of life (qol) among university students in jordan a descriptive studyAlexander Decker
This study examined quality of life (QOL) among 119 nursing students in Jordan using the Medical Outcomes Study Short Form 36 (SF-36). The highest domain score was for physical functioning (78.1) and the lowest was for vitality (52.3). Males scored significantly higher than females on physical functioning. Employed students scored significantly lower than unemployed students on role physical, social functioning, and bodily pain domains. No other demographic factors like clinical course enrollment or GPA were significantly associated with QOL domain scores. This provides preliminary information about nursing student QOL in Jordan.
This document provides details about an upcoming clinical trial course on design, analysis, interpretation and reporting of clinical trials. It includes information about the course faculties from McMaster University and Christian Medical College, Vellore. The 5-day course will cover topics like types of clinical trials, CONSORT guidelines, design considerations, systematic reviews, meta-analysis, statistical analysis methods, sample size calculation and preparing FDA submissions. One of the clinical trials described is about assessing the effect of a preoperative short-term structured exercise program on postoperative quality of recovery in patients undergoing major abdominal cancer surgeries.
Virtual Reality Reflection Therapy Improves Balance and Gait in Patients with...Avi Dey
Technology enhanced version of Mirror Box Therapy called Virtual reality reflection therapy (VRRT) . Taesung In Et Al, (Department of Physical Therapy, College of Health Science, Sahmyook University, Seoul, South Korea) . Referred by Café Twin, Fairfax, VA USA. (LinkedIn.com/Café Twin) 2016
Aderenta la tratamentul inhalator in bolile respiratoriiTraian Mihaescu
The document discusses adherence to inhaler treatment for conditions like asthma and COPD. It begins by explaining how reward circuitry in the brain reinforces behaviors that promote survival. It then defines adherence and compliance, noting that adherence involves active patient participation while compliance is more passive following of doctor's orders. The document outlines factors influencing adherence like treatment complexity and social support. It reviews data showing poor adherence to inhalers and notes lower adherence for pulmonary diseases. Finally, it discusses the importance of patient education and inhaler type on adherence, emphasizing the need for simple, effective treatment plans to improve outcomes.
A randomized, double-blind, placebo-controlled pilot study was conducted to determine if preoperative modafinil improved recovery after general anesthesia in patients with obstructive sleep apnea (OSA). 102 patients with OSA were given either 200mg of modafinil or placebo before surgery. The primary outcome of length of stay in the post-anesthesia care unit (PACU) showed no difference between groups. Secondary measures of emergence and recovery also did not differ significantly. While respiratory rate was higher and blood pressure lower in the modafinil group in the PACU, the study results suggest single-dose preoperative modafinil does not improve functional recovery after general anesthesia in patients with OSA.
This document outlines a proposed study on the efficacy of intravenous lidocaine in preventing fentanyl-induced cough before induction of anesthesia. The study aims to determine if lidocaine reduces the incidence of cough caused by fentanyl injection before anesthesia by 30% compared to placebo. It will involve 96 patients randomized to receive either lidocaine or saline before fentanyl injection. The primary outcome is reduction in cough incidence and secondary outcomes include hemodynamic stability and adverse effects. The proposed methodology describes patient selection criteria, interventions, data collection and analysis in detail.
Dr. Ashutosh Soni has over 15 years of experience in nephrology. He completed his DM in nephrology from Banaras Hindu University in 2011. Since then, he has worked as assistant professor, head of department, and consultant nephrologist at various hospitals in India. Currently, he works as head of nephrology at Monilek Hospital in Jaipur, which has performed over 600 kidney transplants. His clinical expertise includes renal transplantation, dialysis, and management of kidney diseases.
This document presents a research synopsis on assessing the knowledge of renal diet among primary caregivers of renal failure patients. The study aims to evaluate the existing knowledge of primary caregivers regarding renal diet using a questionnaire and to develop a self-instructional module on renal diet. It will recruit 60 primary caregiver samples using non-probability purposive sampling from selected hospitals. Data will be collected using a demographic section and knowledge assessment questionnaire, and analyzed using frequency, percentage, mean and chi-square tests. Findings will be disseminated through publications and workshops.
Ethical and Participant Safety considerations in Clinical TrialsKunal Sampat
This document discusses key ethical considerations for clinical trial protocols and conduct. It outlines standard protocol elements such as format, content, and administrative responsibilities. Some important ethical considerations in protocol development include appropriate inclusion/exclusion criteria, choice of efficacy and safety parameters, and procedures for handling medical emergencies and early trial discontinuation. When conducting trials, important ethical areas are recruiting and screening patients, maintaining confidentiality of data, and following the Declaration of Helsinki for protecting human subjects.
Effect of food on pharmacokinetics of meloxicam ijsit 2.3.7IJSIT Editor
The primary objective of the study was to investigate the effect of food on the pharmacokinetics of
MELOXICAM. Cmax, Tmax and AUC of MELOXICAM were defined as the main parameters for the assessment
of bioavailability and bioequivalence of MELOXICAM administered in fasting and fed conditions. The 90% CI
for the fed/fasting MELOXICAM did not contained within the acceptance interval (80, 125) and, therefore, it
can be concluded that the rate of systemic exposure to MELOXICAM does not fit the claim of bioequivalence
between administration in fasting and fed conditions. This study has demonstrated that all the
pharmacokinetic parameters of both the treatments were statistically different from each other. In the fed
condition the values of Cmax and AUC were decreased while Tmax increases than that of fasting which
demonstrated that the extent of systemic exposure to MELOXICAM was affected by the delay in absorption of
MELOXICAM in the presence of food. None of the study volunteers reported any serious adverse effects
throughout the study. The only two AEs reported were mild and not related to the study medication. The AEs
reported were, according to the study medical expert, related to the sampling procedure and were self
limiting and did not require any treatment. There was no change in the vital signs of the volunteers
throughout the study period. The presented data are of major importance in identifying the optimal dosing
regimen for future clinical trials with oral MELOXICAM. In our study, only one type of food (a standardized
continental breakfast) was evaluated; further studies are needed to assess the effects of foods with different
compositions and contents on the bioavailability of MELOXICAM.
Curriculum Vitae Dr Harsh Vardhan for Consultant 24June2016Harsh Vardhan
Dr. Harsh Vardhan has over 28 years of experience as an anesthesiologist. He has worked in both military and civilian hospitals, providing anesthesia for a wide range of surgical specialties. He has held leadership roles including head of department and professor. Currently he works as a consultant anesthesiologist in Bahrain, where he provides care for general surgery, OB/GYN, orthopedics and other specialties.
Seminar first semester Simvastation in COPDSwty Sweta
This document summarizes a study that investigated whether simvastatin could prevent exacerbations in patients with moderate to severe COPD. The study involved 885 patients randomized to receive either simvastatin 40mg daily or a placebo. The primary outcome was the exacerbation rate, and secondary outcomes included time to first exacerbation, lung function, quality of life, and adverse events. The results showed no significant differences between the simvastatin and placebo groups in exacerbation rate, time to first exacerbation, or secondary outcomes. Simvastatin 40mg daily did not demonstrate a therapeutic benefit for reducing exacerbations in patients with moderate to severe COPD.
Effect of Four -Weeks Yogic Training Program on Selected Hematological Parame...Sports Journal
The aim of present study was to know the Effect of four - weeks yogic training program on selected Hematological parameters among male students. The training was conducted in the morning session of one hour for the period of four- weeks. The study was conducted on higher secondary school level male students. Total ten male students were be selected as subject. These subjects were selected in terms of purposive samples from the 8th, 9th, 10th, 11th and 12th standards from Senior Secondary Model School Punjabi University Patiala. Two Hematological variables namely Erythrocytes and Leucocytes were selected for the purpose of this research. The results of the study reveals that there was significant effect of four weeks yogic protocol on erythrocytes and leucocytes count among male students.
Effect of Emergency Department and ICU Occupancy on Admission Decisions and O...Ching-wen Lu
1) Critically ill patients requesting admission to a busy medical ICU (MICU) had lower odds of acceptance when the MICU was at full capacity, despite availability in other ICUs.
2) For patients both accepted and denied MICU admission, longer boarding times in the emergency department post-consult were associated with higher risk of in-hospital mortality or persistent organ dysfunction.
3) The study highlights the impact of ICU bed availability and emergency department crowding on decisions to admit critically ill patients, and shows that increased boarding time is an independent risk factor for worse patient outcomes.
The document provides an overview of different departments and functions within a hospital pharmacy. It discusses departments like the dispensary, pathology, surgical ward, emergency department and waste management. It also covers various medical tests performed in pathology like the Widal test for typhoid, pregnancy test, and blood glucose test. Common drugs and injections available in the dispensary are also outlined, including those used for pain relief, antibiotics, and allergies. Different routes of drug administration such as oral, intramuscular, intravenous and more are also reviewed.
This document provides definitions for various clinical trial terms. It defines terms like adverse reaction, approval, arm, baseline, bias, blinding, case control study, clinical, clinical investigator, clinical research associate, and many others. For each term there is a brief 1-2 sentence definition explaining the meaning in the context of clinical research.
Background: Optimum learning environments (LEs) are linked with positive training outcomes for residents. However, there is few data concerning how the residents perceive the learning environments in teaching hospitals. This study aims to analyze the residents’ perceptions of their learning environments.
Methods: This cross-sectional, hospital-based study was carried out between November 2020 and January 2021, using a Postgraduate Hospital Educational Environment Measurement (PHEEM) questionnaire. Statistical analysis was conducted using SPSS 20.
Results: The total number was 45 participants, 40 of them successfully responded. The total Cronbach`s alpha score was 0.93, which reflects good reliability. The full-scale score was 128 out of 160, which indicates a good learning environment. The autonomy score was 44, the teachers' score was 50, and social support was 34. Finally, the overall mean score for females was 43.3 compared to 39.4 for males, with a P-value of 0.55. Furthermore, no significant difference in residents’ perceptions of their learning environment according to their training was observed in this study.
Conclusion: Significant challenges in the LE were identified; more attention and effort should be given, especially to the poorly rated point in this study: the existence of an informative program, clear clinical protocols, and proper setting expectations. The lowest score was for catering, housing. A high social support score indicates a healthy workplace environment and job satisfaction.
A study conducted at Children's Hospital of Philadelphia over 7 years involving over 4,400 pediatric catheterization procedures found that operator-directed sedation, where a nurse sedates patients under the supervision of an interventional cardiologist, resulted in fewer adverse events, shorter procedure times, and quicker exit times compared to general anesthesia. However, the study also noted that cardiac anesthesiologists are still important for complex or urgent cases given their specialized expertise.
Dexamethasone trial in chronic subdural hematomaSandesh Dahal
This document summarizes a journal club presentation on a randomized controlled trial investigating the use of dexamethasone for chronic subdural hematoma. The trial found that patients receiving dexamethasone had a less favorable functional outcome at 6 months compared to placebo, as measured by the modified Rankin scale. Secondary outcomes also showed higher rates of adverse events in the dexamethasone group. The results do not support the use of dexamethasone for chronic subdural hematoma as it may be associated with harm.
A Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and ...DeepaKarn
A Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Forskolin Eye Drops 1% in the Treatment of Open AngleGlaucoma – A Comparative Study
This document discusses drug development for rare diseases like Duchenne Muscular Dystrophy (DMD) from an academic and patient perspective. It outlines the involvement of patient communities, importance of timely tool development, and involving all stakeholders. It discusses the development of exon skipping therapy for DMD including preclinical research in cells and mice, early clinical trials, and challenges with placebo-controlled trials due to limited natural history data and outcome measures. Key lessons are the need for natural history data, developing outcome measures with patients, and involving all stakeholders from an early stage.
Role of Biostatistics in Clinical TrialsClinosolIndia
Biostatistics plays a pivotal role in the design, conduct, analysis, and interpretation of clinical trials. This field of statistics is indispensable in ensuring the scientific rigor and validity of clinical research. Here are key aspects of the role of biostatistics in clinical trials
Personalized medicine tools for clinical trials - kuchinkeWolfgang Kuchinke
Tools for personalised medicine in clinical trials. ---------
The implementation of clinical trials in personalized medicine is a different way of doing clinical research compared to the standard way of large clinical trials aiming for statistical significance. Personalized medicine uses a medical model that separates people into different groups with medical decisions, practices, drugs, interventions being tailored to the individual patient based on their predicted response. Basis for this approach is the progress of the study of the human genome and its variation over the last two decades. Especially advancement in automated DNA sequencing and PCR and the use of expressed sequence tags (ESTs), cDNAs, antisense molecules, small nterfering RNAs (siRNAs), full-length genes and their expression products and haplotypes.
But adoption of personalized medicine requires an active and flexible and highly integrated infrastructure, which allows joining of many different competences and technologies. We asked the question: can the tools developed for personalized medicine in the p-pedicine project be employed effectively in a clinical trials network to support personalised clinical trials. We conducted an analysis of tool integration and the evaluation tool usage requirements. Based on the survey results, the tendency for clinical trial network ECRIN is to use software as a service in the form as SaaS or ASP. ECRIN data centres will (probably) not install and employ p-medicine tools in one of their data centres. A robust business model for the provision of services and the implementation and employment of tools does not yet exist.
How can the personalized medicine infrastructure p-medicine and the clinical trials network ECRIN gain from each other to allow the conduct of personalized clinical trials?
We suggest a business model, in which personal medicine infrastructures and clinical trials networks exchange their services to gain jointly from each other. Therefore: an integration by reciprocal exchange of services may be the solution. Not only software as a service will be exchanged, but also knowledge, personnel and joint staff trainings.
Personalized medicine tools for clinical trials - KuchinkeWolfgang Kuchinke
Tools for personalised medicine in clinical trials.
The implementation of clinical trials in personalized medicine is a different way of doing clinical research, compared to the standard way of large clinical trials aiming for statistical significance. Personalized medicine uses a medical model that separates people into different groups with medical decisions, practices, drugs, interventions being tailored to the individual patient based on their predicted response. Basis for this approach is the progress of the study of the human genome and its variation over the last two decades. Especially advancements in automated DNA sequencing, PCR technologies and the use of expressed sequence tags (ESTs), cDNAs, antisense molecules, small interfering RNAs (siRNAs).
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Impact of Dexmedetomidine on the Incidence of Delirium in Elderly Patients after Cardiac Surgery: A Randomized Controlled Trial
1. Pokhara University
School of Health and Allied Sciences
Impact of Dexmedetomidine on the
Incidence of Delirium in Elderly
Patients after Cardiac Surgery: A
Randomized Controlled Trial
Deepa kumari karn
Seminar 1st , Mpharm (C.P)1st sem
5/29/2017 1
2. Pokhara University
School of Health and Allied Sciences
Table of Content
• Introduction
– Delirium
– Dexmedetomidine
• Research Question
• Literature review
• Objective
– General Objective
– Specific Objective
• Rational of the study
• Methods
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3. Pokhara University
School of Health and Allied Sciences
– Study design
– Participants
– Randomization, intervention and anesthesia management
– Outcome assessment and follow-up schedule
– Statistical analysis
• Results
– Patient population
– Effectiveness analysis
– Safety analysis
Discussion
Conclusion
References
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4. Pokhara University
School of Health and Allied Sciences
Introduction
Delirium
• Delirium is common complication after cardiac
surgery, with reported incidences varied from 3% to
47%
• Occurrence of delirium after cardiac surgery is
associated with worse outcomes:
increased rate of complications
prolonged duration of mechanical ventilation
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5. Pokhara University
School of Health and Allied Sciences
Prolonged length of stay in ICU and hospital
increased medical expenses during hospitalization
• Pathogenesis of postoperative delirium is not fully
understood
• Previous studies demonstrated that deep anesthesia
during surgery and use of high doses opiates and/or
sedatives after surgery are important predisposing
factors
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7. Pokhara University
School of Health and Allied Sciences
Dexmedetomidine
Highly selective alpha 2-adrenoceptor agonist with
anxiolytic, sedative, and analgesic properties
Widely used as an adjuvant during general anesthesia
and for sedation during mechanical ventilation after
surgery
• Hypothesized that use of dexmedetomidine as an
anesthetic adjuvant during cardiac surgery decreased
the incidence of delirium, possibly by sparing the
consumption of general anesthetics5/29/2017 7
8. Pokhara University
School of Health and Allied Sciences
Research Question
• Can the use of dexmedetomidine during and shortly
after cardiac surgery decrease the incidence of
delirium in elderly patients?
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9. Pokhara University
School of Health and Allied Sciences
Literature review
• Dexmedetomidine inhibits the noradrenergic nuclei in
the locus ceruleus of the brainstem, inhibits
nociception in spinal cord
• Decreases sympathetic outflow and circulating
catecholamines
• Intraoperatively it provides stable haemodynamic
profile by attenuating stress response during tracheal
intubation, during surgery and emergence from
anesthesia.5/29/2017 9
11. Pokhara University
School of Health and Allied Sciences
• According to the American Psychiatric Association's
Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV), delirium is defined as “a
disturbance of consciousness with reduced ability to
focus, sustain, or shift attention; a change in
cognition; or the development of a perceptual
disturbance that occurs over a short period of time
and tends to fluctuate over the course of the day
• Van Gemert and Schuurmans defined delirium as a
frequent form of psychopathology in elderly
hospitalized patients; it is a symptom of acute
somatic illness”5/29/2017 11
12. Pokhara University
School of Health and Allied Sciences
• Literature showed that 10 to 30% of patients
admitted to a general hospital develop delirium and
a prevalence of up to 60% is recognized in frail
elderly patients
• A delirium is also often misdiagnosed as depression
or dementia, or considered normal behavior in
elderly patients due to the lack of knowledge and
awareness of nurses and doctors
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13. Pokhara University
School of Health and Allied Sciences
Objectives
General Objective:
• To investigate the effect of the dexmedetomidine
administered during and after cardiac surgrey on the
incidence of delirium in the elderly patient
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14. Pokhara University
School of Health and Allied Sciences
Specific Objective:
Assessment of the patient for the eligibility for the
inclusion for the research
Assessment for the delirium
Assessment of the level of sedation on the basis of RAS
scale
Maintenance of the haemodynamic during the surgery
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15. Pokhara University
School of Health and Allied Sciences
Rational of the study
• Studies suggest that the use of dexmedetomidine in
patient under going the cardiac surgery , decrease the
consumption of the opioids and other anesthetic drugs
which provide the baseline idea for this research
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16. Pokhara University
School of Health and Allied Sciences
Methods
Study design
Randomized, double-blind, and placebo-controlled
two-center trial
• Study protocol was approved by the Ethics
Committees of Peking University First Hospital and
Beijing Fuwai Hospital , and was registered with
ClinicalTrials.gov number, NCT02267538
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17. Pokhara University
School of Health and Allied Sciences
Participants
Inclusion criteria:-
– Elderly patients (age 60 years) who were scheduled to
undergo elective coronary artery bypass graft and/or valve
replacement surgery
• Exclusion criteria:-
– Previous history of schizophrenia, epilepsy, Parkinson
disease, or severe dementia
– Inability to communicate because of severe visual/auditory
dysfunction or language barrier
– Previous history of functional neurosurgery or brain injury;
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18. Pokhara University
School of Health and Allied Sciences
– Preoperative sick sinus syndrome, severe bradycardia,
second-degree or above atrioventricular block without
pacemaker
– Severe hepatic insufficiency
– Severe renal insufficiency
– Patient refused to participate in the study
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19. Pokhara University
School of Health and Allied Sciences
Randomization, intervention and anesthesia
management
• Center-stratified randomization with a block size of 4
was done using the SAS statistical package version
9.3
• Study drugs, either dexmedetomidine hydrochloride
200 μg /2 ml or 0.9% sodium chloride 2 ml, were
provided as clear aqueous solutions in the same 3 ml
bottles
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20. Pokhara University
School of Health and Allied Sciences
• Encoded according to the randomization order by an
independent pharmacist who did not participated in
the rest of the study
• Study drugs were diluted with normal saline to 50 ml
before administration, for dexmedetomidine the final
concentration was 4 μg/ml
• Drug infusion was started once the intravenous
access was established, firstly at a rate of [0.9 × kg]
ml/h (i.e., 0.6 μg/kg for dexmedetomidine) for 10
minutes, then at a rate of [0.1 × kg] ml/h (i.e., 0.4
μgkg-1h-1 for dexmedetomidine) until the end of
surgery.
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21. Pokhara University
School of Health and Allied Sciences
• After surgery, study drug infusion was continued at a
rate of [0.025 × kg] ml/h (i.e., 0.1 μgkg-1h-1 for
dexmedetomidine) until the end of mechanical
ventilation
• Anesthesia was induced with midazolam, etomidate,
sufentanil, and propofol, and was maintained with
sufentanil and propofol infusion and/or sevoflurane
inhalation
• All patients were transferred to the intensive care unit
(ICU) after surgery
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22. Pokhara University
School of Health and Allied Sciences
• Patients who required additional analgesia, opiates
were administered either intravenously or orally
• For patients who required sedation (i.e., patients
undergoing mechanical ventilation), propofol
intravenous infusion was the first choice
• For all enrolled patients, Penehyclidine hydrochloride
and scopolamine were prohibited, and open-labled
Dexmedetomidine was not allowed during the whole
study period
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23. Pokhara University
School of Health and Allied Sciences
Outcome assessment and follow-up schedule
• Prior to the study, two investigators (XL and YZ) who
performed interview and delirium assessments were
trained to follow standard procedures and to use the
Confusion Assessment Method (CAM) and the CAM
for the Intensive Care Unit (CAM-ICU) by a
psychiatrist
• Before surgery, detailed baseline data including
demographics, comorbidities, medication, laboratory
test results, diagnosis, and ASA classification were
collected. Preoperative evaluations were performed
5/29/2017 23
25. Pokhara University
School of Health and Allied Sciences
• Intraoperative data including type of surgery, duration
of anesthesia and surgery, names and doses of
anesthetic drugs, use and duration of
cardiopulmonary bypass and aortic crossclamping,
transfusion of blood products, and fluid balance were
recorded
• Delirium was assessed daily (from 8 to 10 am) during
postoperative days 1 to 5
• For patients who were discharged or died before
postoperative day 5, the results of last delirium
assessment were used as the missing data5/29/2017 25
26. Pokhara University
School of Health and Allied Sciences
• On postoperative day 6, cognitive function was
reevaluated using the MMSE; the duration of
mechanical ventilation, the length of stay in the ICU
and hospital after surgery, and the occurrence of non-
delirium complications were recorded
• The primary endpoint was the incidence of delirium
within the first five days after surgery.
5/29/2017 26
27. Pokhara University
School of Health and Allied Sciences
• Secondary endpoints included the cognitive function
assessed on postoperative days 6 and 30, the overall
incidence of non-delirium complications within 30
days after surgery, and the all-Dexmedetomidine and
delirium after cardiac surgery cause 30-day mortality
• Other predefined endpoints included the severity of
pain and subjective sleep quality during the first 5
days after surgery, the duration of mechanical
ventilation, the length of stay in ICU and hospital
after surgery, and the re-hospitalization rate within 30
days after surgery
5/29/2017 27
29. Pokhara University
School of Health and Allied Sciences
Statistical analysis
Sample size estimation
– It was assumed that the incidence of delirium after cardiac
surgery was 30% in the CTRL group patients
– A meta-analysis showed that the incidence of delirium was
reduced by 63% when dexmedetomidine was used for
sedation in patients after cardiac surgery
– Sample size calculation was performed with the PASS 11.0
software
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30. Pokhara University
School of Health and Allied Sciences
Outcome analyses
– Continuous variables with normal distribution were
analyzed using the unpaired t-test
– Continuous variables with abnormal distribution or ordinal
data were analyzed with Mann-Whitney U test
– Outcome and safety data were analyzed in the intent-to-
treat population
– Statistical analysis was performed with SAS statistical
package
5/29/2017 30
31. Pokhara University
School of Health and Allied Sciences
Results
Patient population
Fig :- Flow Diagram of the study. DEX, dexmedetomidine;
CTRL, control; ITT, Intention-to-Treat.
5/29/2017 31
32. Pokhara University
School of Health and Allied Sciences
Effectiveness analysis
• There was no significant difference between the two
groups regarding the incidence of delirium during the
first 5 days after surgery
• There were no significant differences between the
two groups regarding the overall incidence of non-
delirium complications within 30 days after surgery
• The intensity of pain both at rest and with coughing
as well as the subjective sleep quality at postoperative
days 1 to 5 were similar between the two groups
5/29/2017 32
33. Pokhara University
School of Health and Allied Sciences
• The duration of mechanical ventilation was shorter in
the DEX group than in the CTRL group, the
percentage of patients extubated within 24 hours after
surgery was higher in the DEX group than in the
CTRL group
• There were no significant differences between the
two groups regarding the incidence of coma within 5
days after surgery, the duration of delirium, the
lengths of stay in ICU and hospital after surgery, and
the rate of re-hospitalization within 30 days after
surgery
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34. Pokhara University
School of Health and Allied Sciences
Safety analysis
• The percentage of patients requiring intraoperative
treatment for tachycardia was lower in the DEX
group than in the CTRL group
• The percentage of patients requiring postoperative
treatment for hypotension was higher in DEX group
than in the CTRL group
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36. Pokhara University
School of Health and Allied Sciences
Discussion
• Dexmedetomidine infusion decreased the required
treatment for intraoperative tachycardia but
increased the required treatment for postoperative
hypotension
• In this research, the incidence of delirium in the CTRL
group was 7.7%, much lower than our and others'
previous studies because of :-
– Anticholinergic drugs were less used in the current study
– benzodiazepines were much less used than previously
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37. Pokhara University
School of Health and Allied Sciences
– delirium-preventing measures were used more commonly
in daily nursing practice, including reorientation, cognitive
stimulating,sleep promotion, and hearing/vision aids
• Dexmedetomidine produces a mild analgesic effect
by activating the α2 adrenoceptors in the spine cord
• Dexmedetomidine produces a hypnotic effect by
activating the endogenous sleep-promoting pathway
and improves the sleep quality in mechanically
ventilated patients
5/29/2017 37
38. Pokhara University
School of Health and Allied Sciences
• Use of dexmedetomidine did not decrease the overall
incidence of nondelirium complications, but it tended
to decrease the incidence of pulmonary complications
after surgery
• Duration of mechanical ventilation was shortened and
the percentage of extubation within 24 hours after
surgery was increased in the DEX group
• Decrease the required t/t for intraoperative
tachycardia; increase the required t/t for postoperative
hypotension and thus, its safety, other benefits and
long-term outcome are subjected to study further5/29/2017 38
39. Pokhara University
School of Health and Allied Sciences
• Several limitations of this study was:-
– Patients who were unable to communicate due to
visual/auditory dysfunction, language barrier or psychiatric
disease, and those with severe hepatic or kidney disease
were excluded
– Delirium was assessed once daily in the present study
– Because of the low incidence of delirium in the CTRL
group, this trial was underpowered to detect difference
between the two groups
5/29/2017 39
40. Pokhara University
School of Health and Allied Sciences
Conclusions
• Dexmedetomidine administered during anesthesia
and early postoperative period did not decrease the
incidence of postoperative delirium in elderly patients
undergoing elective cardiac surgery
• Dexmedetomidine decreased the required treatment
for intraoperative tachycardia, but increased the
required treatment for postoperative hypotension
5/29/2017 40
41. Pokhara University
School of Health and Allied Sciences
Reference
1. Li X, Yang J, Nie, Zhang Y, Huan L, Wang D, Ma D
(2017), Impact of dexmedetomidine on the
incidence of delirium in elderly patients after
cardiac surgery: A randomized controlled trial. PLoS
ONE 12(2): e0170757. doi:10.1371/journal
pone.0170757, 1-15.
2 Jethva K and Shan R, Dexmedetomidine as an
Adjuvant in General Anaesthesia (2013)
International Journal for Scientific Research , 2(11),
355-357.5/29/2017 41
42. Pokhara University
School of Health and Allied Sciences
3. Koster S, Delirium in Cardiac Surgery (2011)
University of Twente , 1-150.
5/29/2017 42