1. Temperature and Comfort Study(TaCS) Preventing inadvertent perioperative hypothermia in elective arthroscopic shoulder surgery: A protocol for a randomised controlled trial By Renatta DiStaso and Kerry-Anne Cobbe
2. Research Team Nicole Draper (NUM) Professor Kim Walker (NRI) Kerry-Anne Cobbe (CNS) Renatta Di Staso (CNS) Jed Duff (Research Fellow) Professor Sandy Middleton (NRI) Dr. Simon Tan (Orthopaedic surgeon) Dr. Emma Halliday (Anaesthetist) Associate Professor Lawrence Lam (Statistician) Todd Allen (Research Assistant) DSU Staff
3. Session Overview Background Inadvertent perioperative hypothermia Literature review Time line: research process Temperature and Comfort Study (TaCS): protocol Ethical Issues Stumbling blocks
4. Context St Vincent’s Private is a 25o bed acute care private hospital catering for all major specialities excluding maternal and paediatric care Day Surgery 5 operating theatres 1 lithotripsy suite 2 treatment rooms Approximately 10,000 cases with 1/3 planned overnight stay
5. Background Research all starts with an idea...How can nurses better care for patients to see better outcomes and improve recovery time. As clinicians the easiest way to become involved in research in your own practice is to answer your own clinical problems.
6. Literature Review Perioperative hypothermia is core temperature below 36°C Contributing factors: Reduced metabolic heat production due to anaesthetic Cold perioperative environment Impaired thermoregulation. Linked to poorer postoperative outcomes, extended recovery stay & increased resource use.
7. Literature review Literature says that active and passive measures for preventing perioperative hypothermia are as follows: Warm blankets Forced air warming gowns and blankets Space blankets Warm irrigation fluids
8. Time line July 2009: Initial Idea July- October 2009: Development of idea, study proposal October 2009: Application for Research Grant January 2010: Nursing Research grant approved March 2010: Ethics Approval Application May 2010 Feasibility study : Forced Air Warming Study (FAWS)
9. Time line.... July 2010: Ethics Approval Commenced staff education Australian and New Zealand Clinical Trials Register September 3rd 2010: 1st patient recruited January 31st 2011: 40 patients
10. Purpose The effects of pre-warming and/or warmed irrigation fluids on elective arthroscopic shoulder surgery patients’ Temperature Thermal comfort Total recovery time
11. Study Design Randomised 2x2 factorial design Study groups: 4 Participants: 12o Duration: 12-16 months
12. Participant Selection Inclusion Criteria Exclusion Criteria Elective arthroscopic shoulder surgery >/=18years ASA grade 1-111 Willing & able to give consent BMI <18.5 or >40 Preop temperature >37.5 Unable to speak or understand English
13. Randomisation in Clinical Trials Randomisation is the process of assigning clinical trail participants to treatment groups. Allocation is carried out using a chance mechanism so that neither the participant nor the investigator will know in advance which will be assigned.
15. Stumbling Blocks Research: terminology, literature review, critiquing Computer skills: excel, designing data collection forms, statistics Time
16. Thank you We would like to acknowledge: St Vincent’s & Mater Health Sydney Research Grants (2010-2011) SV&MHS Nursing Research Institute (NRI) NUM – Nicole Draper Professor Kim Walker, Professor Sandy Middleton and Research Fellow Jed Duff for their ongoing support and encouragement.
Editor's Notes
We are presenting today on behalf of our research team
Where did it all start?
2. Cold theatre, cold table, cold skin prep and cold irrigation fluids3. Myocardial ischaemia, surgical site infection and coagulopathy
Thermal comfort: Important because temperature plays an integral component of patients perception of well being and thermal discomfort during the perioperative period has been shown to significantly affect their overall experience.
A factorial design involves the measuring of two or more independent variables on a dependent variable. Eg We want to measure the effects of either pre-warming and/or warm irrigation fluids (independent variables) on the patients temperature, thermal comfort and recovery time (Dependent variables)
American Society of Anaesthesiologists
This eliminates any systematic bias in the groups that may affect the variable being studied.This allows comparisons to be made between the different treatments and the results can be compared to see which treatment is best.Randomisation is done Trial statistician who has designed a computer generated program and we have used an independent call system.
Both the consent and information package needed to be worded in a way that the participant could understand and feel that they weren’t being coerced into participating and was approved by the ethics committee. PSee protocol: 5.6 consent, point 7 blinding. 9 data collection
