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 |
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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 |
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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 |
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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:
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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 |