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JOURNAL CLUB
CHAIRPERSON : DR. DIWAKAR T N
HEAD OF UNIT, PROFESSOR
CO-CHAIRPERSON : DR. HEMA CHANDRA
DR . SANJAYKUMAR H R
SENIOR RESIDENT : DR. NISHA
CMO : DR LOKESH
PRESENTER: DR. NAVEENKUMAR T
FIRST YEAR POSTGRADUATE
EFFECT OF NONINVASIVE AIRWAY
MANAGEMENT OF COMATOSE PATIENTS
WITH ACUTE POISONING
: A RANDOMIZED CLINICAL TRAIL
JAMA. 2023;330(23):2267-2274.
Published online November 29, 2023.
INDEX
 INTRODUCTION
 NEED FOR THE STUDY
 OBJECTIVES
 METHODOLOGY
 ENROLLMENT AND INTERVENTION
 OUTCOME MEASURES AND ENDPOINTS
 DISCUSSION
 LIMITATIONS
 CONCLUSION
 REVIEW OF LITERATURE
 REFERENCES
INTRODUCTION
Acute poisoning caused by alcohol , drugs or medication is a
common nontraumatic reason for a decreased level of
consciousness and often associated with a high rate of
intubation.
 Intubation and mechanical ventilation are complex , resource
intensive procedure with associated complication , both
acutely (airway trauma , hypoxia , hypotension , arrest and
aspiration ), and in the longer term (ventilator- associated
pneumonia and psychological sequale).
INTRODUCTION
Despite these trade-offs, there is no study with a
high level of evidence to guide the decision to
intubate or not among comatose patients with
acute poisoning.
NEED FOR THE STUDY
Invasive airway management in comatose patients
with acute poisoning is associated with high rate of
ICU admission ,long length of ICU and hospital stay and
associate complication due to intubation.
 It is an randomized clinical trial tested whether a
strategy of withholding intubation in comatose
patients with suspected acute poisoning is associated
with significant reduction of in-hospital deaths, ICU
admission, length of ICU and hospital stay and adverse
events in the intervention group.
 Intubating a patient with overdose purely for
‘airway protection’, without considering an
individualized risk assessment, is outdated,
detrimental to patient care and resource
allocation, and leads to unnecessary practice
variation.
OBJECTIVES
 To determine the effect of intubation
withholding vs routine practice on clinical
outcomes of comatose patients with acute
poisoning and a Glasgow Coma Scale score
less than 9
STUDY DESIGN, SETTING AND
PARTICIPITANTS
 STUDY DESIGN- This was a multicentre , randomized trial
conducted in 20 emergency departments and 1 intensive
care unit .
 STUDY PERIOD –May 16 ,2021 - April 2023 and followed up
until May 12 , 2023 .
 DURATION OF STUDY – 24 MONTHS
INCLUSION CRITERIA
 Adult patients aged more than 18 years
with a clinical suspicion of acute poisoning
with decreased level of consciousness with
a GCS score less than 9.
EXCLUSION CRITERIA
 Pregnant women .
 Incarcerated or Involuntarily detained patients .
 Patient who need immediate tracheal intubation
 signs of respiratory distress
 clinical suspicion of any brain injury
 seizure or shock
 Patients were also excluded if there was a suspicion of cardiotropic
drug poisoning (beta blockers , calcium channel blockers and ACE
inhibitors).
 Single toxic substance poisoning that could be reversed (opioids and
benzodiazepines)
ENROLLMENT AND INTERVENTION
 Patients were randomly assigned in a 1:1 ratio to the
control or the intervention group.
 In the intervention group, intubation was withheld unless
an emergency intubation criterion was met.
 In the control group, the decision to intubate was left at
the discretion of the treating emergency physician.
OUTCOME MEASURES AND END POINTS
 The mean age was 33 years (IQR, 25-49) and 85 (38%) were female. The
median GCS score at inclusion was 6 (IQR, 3-7) and the main toxin was
alcohol (67%).
 Fewer patients were intubated in the intervention group than in the
control group (19 patients [16.4%] vs 63 [57.8%], respectively.
 Among 19 patients who were intubated in the intervention group, 16
presented with at least 1 criteria of emergency intubation, including 4
patients within 30 minutes, 8 patients between 30 minutes and 2 hours,
and 4 patients between 2 hours and 4 hours after enrollment
DISCUSSION
 In this study withholding intubation in comatose patients with
suspected acute poisoning showed significant reduction in in-
hospital deaths, length of ICU stay and reduction in ICU
admission in the intervention group.
 A conservative strategy can be used to avoid unnecessary
intubation in comatose patients after acute poisoning and could
lead to a lower risk of adverse events.
 The first pass failure rate was monitored as a validated surrogate
for adverse events among those intubated, the rate was lower for
the intervention group compared with the control group.
There was a significant clinical benefit for the
primary end point in the intervention group, with a
win ratio of 1.85 (95% CI, 1.33 to 2.58)
LIMITATIONS
 Because the trial was unblinded, a Hawthorne effect may have influenced physician
behavior and the decision to intubate.
 Aim of this study is to see no. of death, length of ICU stay, and length of hospital stay.
But there were no deaths seen in the study population, and there was no ICU admission
in 1 of 5 patients. As such, the main benefit for the composite primary end point is
driven by the reduction in ICU admission and length of ICU and hospital stay.
 Differences in intubation location for comatose patients may contribute to the study
findings.
 Patients were included if there was a suspicion of acute poisoning, which was not
ascertained in all patients.
 The GCS was not explicitly designed to guide clinical prediction of the risk of aspiration
or need for tracheal intubation
Scoring system used to evaluate need
for ICU intervention in patient with
acute poisoning with drug overdose
 COBRA DECISION TOOL
 RAPID EMERGENCY MEDICINE SCORE
 RAPID ACUTE PHYSIOLOGY SCORE
 APACHE II SCORE
 BISPECTRAL INDEX
CONCLUSION
 Among comatose patients with suspected
acute poisoning, a conservative strategy of
withholding intubation was associated with
a greater clinical benefit for the composite
end point of in-hospital death, length of
ICU stay, and length of hospital stay.
REVIEW OF LITERATURE
 Avoiding intubation can
protect patients from
complication associated with
using a ventilator, risk of
nosocomial infections, risk
of additional sedative
medications and prolonged
hospitalization.
 From resource perspective ,
the institutions can use
limited critical care
capacity for other patients,
and shorter length of stay
can allow bed turnover to
be increased
Qasim Z, Perrone J, Delgado MK. The
Value of Not Intubating Comatose
Patients With Acute Poisoning. JAMA.
2023 Dec 19;330(23):2253-2254.
Review of literature
 In this study suggests that
conservative airway
management for patients
with a decreased GCS due to
suspected GHB intoxication
may be safe.
 Major adverse events were
present in 2.4% of patients,
only 1.4% of patients
required intubation. All
minor adverse events were
managed effectively with
conservative treatment.
van Helmond LP, Gresnigt FM.
Safety of withholding
intubation in gamma-
hydroxybutyrate-and gamma-
butyrolactone-intoxicated coma
patients in the emergency
department. European Journal
of Emergency Medicine. 2020
Jun 1;27(3):223-7.
REVIEW OF LITERATURE
 Invasive mechanical ventilation should be
regarded as the definite procedure for
severely ill patients with drug overdose.
 Alternatively, NIV might be an acceptable
choice for selected cases of relatively stable
patients with a low risk of aspiration and
absence of overt signs of multiple organ
failure. In these cases, a trial of NIV could be
cautiously offered and patient is being
carefully monitored.
 In addition, NIV might be considered for the
management of drug overdose-associated
respiratory failure when a “do-not-intubate”
decision has been made
 Agrafiotis, M., Serasli, E.,
Tsara, V. (2016). Noninvasive
Ventilation in Drug Overdose: Is
It a Potentially Safe
Application? Key Practical
Implications. In: Esquinas, A.
(eds) Noninvasive Mechanical
Ventilation. Springer,
REFERENCES
 Freund Y, Viglino D, Cachanado M, Cassard C, Montassier E, Douay B, Guenezan J, Le Borgne P,
Yordanov Y, Severin A, Roussel M. Effect of noninvasive airway management of comatose
patients with acute poisoning: a randomized clinical trial. JAMA. 2023 Dec 19;330(23):2267-74.
 Pellatt RA, Isoardi K, Keijzers G. Intubation for patients with overdose: Time to move on from
the Glasgow Coma Scale. Emergency Medicine Australasia. 2023 May 29.
 Wiersma T, van den Oever HL, van Hout FJ, Twijnstra MJ, Mauritz GJ, van’t Riet E, Jansman FG.
The performance of COBRA, a decision rule to predict the need for intensive care interventions
in intentional drug overdose. European Journal of Emergency Medicine. 2022 Apr 1;29(2):126-33.
 El-Sarnagawy GN, Hafez AS. Comparison of different scores as predictors of mechanical
ventilation in drug overdose patients. Hum Exp Toxicol. 2017 Jun;36(6):539-5
 Burket GA et al . Endotracheal intubation in the pharmaceutical-poisoned patient: a narrative
review of the literature. Journal of Medical Toxicology. 2021 Jan;17:61-9.
THANK YOU

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Presenting a journal club in postgraduate course

  • 1. JOURNAL CLUB CHAIRPERSON : DR. DIWAKAR T N HEAD OF UNIT, PROFESSOR CO-CHAIRPERSON : DR. HEMA CHANDRA DR . SANJAYKUMAR H R SENIOR RESIDENT : DR. NISHA CMO : DR LOKESH PRESENTER: DR. NAVEENKUMAR T FIRST YEAR POSTGRADUATE
  • 2. EFFECT OF NONINVASIVE AIRWAY MANAGEMENT OF COMATOSE PATIENTS WITH ACUTE POISONING : A RANDOMIZED CLINICAL TRAIL JAMA. 2023;330(23):2267-2274. Published online November 29, 2023.
  • 3. INDEX  INTRODUCTION  NEED FOR THE STUDY  OBJECTIVES  METHODOLOGY  ENROLLMENT AND INTERVENTION  OUTCOME MEASURES AND ENDPOINTS  DISCUSSION  LIMITATIONS  CONCLUSION  REVIEW OF LITERATURE  REFERENCES
  • 4. INTRODUCTION Acute poisoning caused by alcohol , drugs or medication is a common nontraumatic reason for a decreased level of consciousness and often associated with a high rate of intubation.  Intubation and mechanical ventilation are complex , resource intensive procedure with associated complication , both acutely (airway trauma , hypoxia , hypotension , arrest and aspiration ), and in the longer term (ventilator- associated pneumonia and psychological sequale).
  • 5. INTRODUCTION Despite these trade-offs, there is no study with a high level of evidence to guide the decision to intubate or not among comatose patients with acute poisoning.
  • 6. NEED FOR THE STUDY Invasive airway management in comatose patients with acute poisoning is associated with high rate of ICU admission ,long length of ICU and hospital stay and associate complication due to intubation.  It is an randomized clinical trial tested whether a strategy of withholding intubation in comatose patients with suspected acute poisoning is associated with significant reduction of in-hospital deaths, ICU admission, length of ICU and hospital stay and adverse events in the intervention group.
  • 7.  Intubating a patient with overdose purely for ‘airway protection’, without considering an individualized risk assessment, is outdated, detrimental to patient care and resource allocation, and leads to unnecessary practice variation.
  • 8. OBJECTIVES  To determine the effect of intubation withholding vs routine practice on clinical outcomes of comatose patients with acute poisoning and a Glasgow Coma Scale score less than 9
  • 9. STUDY DESIGN, SETTING AND PARTICIPITANTS  STUDY DESIGN- This was a multicentre , randomized trial conducted in 20 emergency departments and 1 intensive care unit .  STUDY PERIOD –May 16 ,2021 - April 2023 and followed up until May 12 , 2023 .  DURATION OF STUDY – 24 MONTHS
  • 10. INCLUSION CRITERIA  Adult patients aged more than 18 years with a clinical suspicion of acute poisoning with decreased level of consciousness with a GCS score less than 9.
  • 11. EXCLUSION CRITERIA  Pregnant women .  Incarcerated or Involuntarily detained patients .  Patient who need immediate tracheal intubation  signs of respiratory distress  clinical suspicion of any brain injury  seizure or shock  Patients were also excluded if there was a suspicion of cardiotropic drug poisoning (beta blockers , calcium channel blockers and ACE inhibitors).  Single toxic substance poisoning that could be reversed (opioids and benzodiazepines)
  • 12. ENROLLMENT AND INTERVENTION  Patients were randomly assigned in a 1:1 ratio to the control or the intervention group.  In the intervention group, intubation was withheld unless an emergency intubation criterion was met.  In the control group, the decision to intubate was left at the discretion of the treating emergency physician.
  • 13.
  • 14.
  • 15.
  • 16. OUTCOME MEASURES AND END POINTS  The mean age was 33 years (IQR, 25-49) and 85 (38%) were female. The median GCS score at inclusion was 6 (IQR, 3-7) and the main toxin was alcohol (67%).  Fewer patients were intubated in the intervention group than in the control group (19 patients [16.4%] vs 63 [57.8%], respectively.  Among 19 patients who were intubated in the intervention group, 16 presented with at least 1 criteria of emergency intubation, including 4 patients within 30 minutes, 8 patients between 30 minutes and 2 hours, and 4 patients between 2 hours and 4 hours after enrollment
  • 17.
  • 18. DISCUSSION  In this study withholding intubation in comatose patients with suspected acute poisoning showed significant reduction in in- hospital deaths, length of ICU stay and reduction in ICU admission in the intervention group.  A conservative strategy can be used to avoid unnecessary intubation in comatose patients after acute poisoning and could lead to a lower risk of adverse events.  The first pass failure rate was monitored as a validated surrogate for adverse events among those intubated, the rate was lower for the intervention group compared with the control group.
  • 19. There was a significant clinical benefit for the primary end point in the intervention group, with a win ratio of 1.85 (95% CI, 1.33 to 2.58)
  • 20. LIMITATIONS  Because the trial was unblinded, a Hawthorne effect may have influenced physician behavior and the decision to intubate.  Aim of this study is to see no. of death, length of ICU stay, and length of hospital stay. But there were no deaths seen in the study population, and there was no ICU admission in 1 of 5 patients. As such, the main benefit for the composite primary end point is driven by the reduction in ICU admission and length of ICU and hospital stay.  Differences in intubation location for comatose patients may contribute to the study findings.  Patients were included if there was a suspicion of acute poisoning, which was not ascertained in all patients.  The GCS was not explicitly designed to guide clinical prediction of the risk of aspiration or need for tracheal intubation
  • 21.
  • 22. Scoring system used to evaluate need for ICU intervention in patient with acute poisoning with drug overdose  COBRA DECISION TOOL  RAPID EMERGENCY MEDICINE SCORE  RAPID ACUTE PHYSIOLOGY SCORE  APACHE II SCORE  BISPECTRAL INDEX
  • 23.
  • 24.
  • 25. CONCLUSION  Among comatose patients with suspected acute poisoning, a conservative strategy of withholding intubation was associated with a greater clinical benefit for the composite end point of in-hospital death, length of ICU stay, and length of hospital stay.
  • 26.
  • 27.
  • 28. REVIEW OF LITERATURE  Avoiding intubation can protect patients from complication associated with using a ventilator, risk of nosocomial infections, risk of additional sedative medications and prolonged hospitalization.  From resource perspective , the institutions can use limited critical care capacity for other patients, and shorter length of stay can allow bed turnover to be increased Qasim Z, Perrone J, Delgado MK. The Value of Not Intubating Comatose Patients With Acute Poisoning. JAMA. 2023 Dec 19;330(23):2253-2254.
  • 29.
  • 30. Review of literature  In this study suggests that conservative airway management for patients with a decreased GCS due to suspected GHB intoxication may be safe.  Major adverse events were present in 2.4% of patients, only 1.4% of patients required intubation. All minor adverse events were managed effectively with conservative treatment. van Helmond LP, Gresnigt FM. Safety of withholding intubation in gamma- hydroxybutyrate-and gamma- butyrolactone-intoxicated coma patients in the emergency department. European Journal of Emergency Medicine. 2020 Jun 1;27(3):223-7.
  • 31.
  • 32. REVIEW OF LITERATURE  Invasive mechanical ventilation should be regarded as the definite procedure for severely ill patients with drug overdose.  Alternatively, NIV might be an acceptable choice for selected cases of relatively stable patients with a low risk of aspiration and absence of overt signs of multiple organ failure. In these cases, a trial of NIV could be cautiously offered and patient is being carefully monitored.  In addition, NIV might be considered for the management of drug overdose-associated respiratory failure when a “do-not-intubate” decision has been made  Agrafiotis, M., Serasli, E., Tsara, V. (2016). Noninvasive Ventilation in Drug Overdose: Is It a Potentially Safe Application? Key Practical Implications. In: Esquinas, A. (eds) Noninvasive Mechanical Ventilation. Springer,
  • 33.
  • 34. REFERENCES  Freund Y, Viglino D, Cachanado M, Cassard C, Montassier E, Douay B, Guenezan J, Le Borgne P, Yordanov Y, Severin A, Roussel M. Effect of noninvasive airway management of comatose patients with acute poisoning: a randomized clinical trial. JAMA. 2023 Dec 19;330(23):2267-74.  Pellatt RA, Isoardi K, Keijzers G. Intubation for patients with overdose: Time to move on from the Glasgow Coma Scale. Emergency Medicine Australasia. 2023 May 29.  Wiersma T, van den Oever HL, van Hout FJ, Twijnstra MJ, Mauritz GJ, van’t Riet E, Jansman FG. The performance of COBRA, a decision rule to predict the need for intensive care interventions in intentional drug overdose. European Journal of Emergency Medicine. 2022 Apr 1;29(2):126-33.  El-Sarnagawy GN, Hafez AS. Comparison of different scores as predictors of mechanical ventilation in drug overdose patients. Hum Exp Toxicol. 2017 Jun;36(6):539-5  Burket GA et al . Endotracheal intubation in the pharmaceutical-poisoned patient: a narrative review of the literature. Journal of Medical Toxicology. 2021 Jan;17:61-9.