Fallis 2006.
Methods | Design: RCT Operative phase: intraoperative Withdrawals: not stated Setting: 2 acute‐care hospitals (Canada) Sample size: 62 Funding: supported by the Health Sciences Center Foundation, Winnipeg, Manitoba. Equipment was donated by Associated Health Systems Inc. (Bair Hugger devices) and Alaris Medical (IV AC thermometers) |
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Participants | Age (mean): 30 years Gender (M/F): 0/62 ASA grade: not stated Surgery type: elective cesarean delivery in low‐risk pregnant women Surgery duration < 2 hrs (70.6/79.5 mins) (total time in OR) Anaesthesia type: neuraxial spinal |
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Interventions |
Intervention (ABSW): n = 32 Forced‐air warming blanket (Bair Hugger® Model 500, Arizant Healthcare, Eden Prairie, MN) Duration: following the insertion of the spinal needle and until the mother left the OR Temperature: warming unit turned on “high” (˜43°C) Body area covered: upper torso and arms Proportion covered: not stated Control: n = 30 Warmed cotton blankets Duration: following the insertion of the spinal needle and until the mother left the OR Co‐interventions: participants in both groups received IV fluids from the IV warming cupboard Room temperature: 21.6°C |
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Outcomes | Thermal comfort (VNRS 0 ‐ 10 scale) (reported only in narratively) Shivering (4‐point scale) (no data reported) Pain (VAS 0 ‐ 10) 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) | Unclear risk | Blocked randomization |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label |
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 | All randomized participants were analysed |
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 |