SAQ 196 – Research – designing and implementing a cooling trial

Question 3. designing and implementing a cooling trial.

a. Scientific design

• Define the study aims and hypothesis.
• Choose a study design, preferably a randomised controlled trial.
• Define the control group.
• Perform sample-size and power calculations.
• Define outcome measures and follow-up period.
• Address blinding limitations.
• Consider multicentre recruitment and collaboration with experienced researchers.

b. Implementation

• Assemble internal and external personnel, including ICU and cardiology.
• Obtain finance approval and research funding.
• Provide equipment, cold fluids, and refrigeration.
• Obtain mandatory ethics and governance approval, including consent arrangements.
• Plan data collection and storage.
• Plan statistical analysis.
• Educate staff and monitor participation and protocol compliance.