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. 2016 Apr 21;2016(4):CD009016. doi: 10.1002/14651858.CD009016.pub2

Frank 1997.

Methods Design: RCT
Operative phase: intraoperative
Follow‐up:
Withdrawals: 30/300 (10%)
Setting: 1 centre (USA)
Sample size: 300 participants > 60 yrs at high risk of cardiovascular events
Funding: National Institutes of Health grant GM38177 and Mallinckrodt Medical Inc. Dr Fleisher was supported by the Richard Ross Clinician Scientist Award of The Johns Hopkins University School of Medicine. The ambulatory ECG recorders were donated by Spacelabs Medical Inc
Participants Age (mean): 71 years
Gender (M/F): 167/133
ASA grade: I ‐ IV
Surgery type: elective (peripheral vascular, abdominal or thoracic procedures)
Surgery duration: > 2 hrs (3.4/3.6 hrs )
Anaesthesia type: general and epidural
Interventions Intervention (ABSW): n = 142
Forced‐air warming cover (Mallinckrodt Medical®)
Duration: not stated
Temperature: Set to maintain core temp at 37°C
Body area covered: legs and trunk
Proportion covered: not stated
Control: n = 158
1 layer of paper of surgical field
Duration: not stated
Control body area covered: not stated
Proportion covered: not stated
Co‐interventions: IV fluids and blood were warmed, and a heat‐moisture exchanger (Thermovent) was used in the respiratory circuit
Outcomes All‐cause mortality
Cardiac events (electrocardiographic and morbid intraoperative and postoperative events: unstable angina/ischaemia, cardiac arrest, or myocardial infarction)
Pain (VAS 0 ‐ 10) 30 and 90 mins postoperatively and the day after surgery
Shivering (present/absent)
Blood loss (ml)
Fluids infused (crystalloids) (ml)
Transfusions (RBC) (Units)
Other outcomes reported not included in the review:
  • Postoperative ventricular tachycardia

  • Arterial blood pressure > limit

  • Heart rate > 100%

  • Requirement for antihypertensive therapy and drug treatment of tachycardia in the first 24 hours postoperatively

  • Hematocrit (1 day postoperatively)

  • % participants requiring postoperative mechanical ventilation

  • IV morphine requirement

  • Length of stay (ICU, hospital)

Notes Comparison 1
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomization sequence.
Allocation concealment (selection bias) Low risk Opaque, sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Participants were not informed of their treatment assignment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Morbid cardiac events were determined by a blinded investigator. All ECGs and enzyme CK data were masked, as well as the Holter tapes
Baseline comparability of groups Low risk To a high extent according to Table 1
Co‐interventions equal between groups Low risk Yes
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 30 participants withdrawn because Holter monitoring data were missing (n = 15 hypothermic group, n = 15 in normothermic group)
Selective reporting (reporting bias) Unclear risk We did not have access to the protocol, therefore we cannot exclude risk of selective reporting with the information provided
Other bias Low risk