Horn 2012.
Methods | Design: RCT Operative phase: preoperative Withdrawals: none Setting: 1 centre (Germany) Sample size: 200 Funding: no funding or competing interests declared |
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Participants | Age (mean): 49/55 years Gender (M/F): 61/139 ASA grade: I ‐ II Surgery type: elective (laparoscopic cholecystectomy; inguinal hernia repair; breast surgery; minor orthopaedic surgery; and ENT surgery) Surgery duration: < 2 hrs (60/65 mins) Anaesthesia type: general |
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Interventions |
Intervention (ABSWa): n = 52 Forced‐air warming (Level 1 Snuggle Warm Upper Body Blanket; Smiths Medical, Rockland, MA, USA) for 10 mins preoperative, set at 44ºC during the warming period Intervention (ABSWb): n = 43 Same (forced‐air warming) for 20 mins preoperatively Intervention (ABSWc): n = 50 Same (forced‐air warming) for 30 mins preoperatively Body area covered: whole body Control: n = 55 Passive insulation with a single cotton blanket Co‐interventions: all IV fluids administered were warmed to 39ºC. In all groups, participants were covered with cotton blankets intra‐ and postoperatively Room temperature: 23ºC |
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Outcomes | Shivering (4‐point scale) Thermal comfort (sensation) (VAS 0 ‐ 100) Blood loss (no data provided) Fluids infused (no data provided) Other outcomes reported not included in the review:
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Notes |
Comparison 1 The 3 intervention groups have been merged in the analysis, giving 1 single comparison Comparison 3 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was performed by rolling a modified dice with 4 faces, each representing 1 of the 4 treatment groups |
Allocation concealment (selection bias) | Unclear risk | No |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It was not possible to blind participants or personnel due to the nature of the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | After the pre‐warming procedure, participants were transferred to theatre. General anaesthesia was induced by an anaesthetist blinded to the pre‐warming randomization. Shivering was assessed by an independent blinded observer |
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 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 |