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

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)
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
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
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:
  • Dose of fentanyl

  • Dose of intrathecal morphine

  • Neonatal outcomes

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