Bernard 2012.
Methods | Parallel‐group, randomized trial, October 2005 to November 2007, multicentre study | |
Participants | Total number of participants 163, mean age 62 years, 36% female, patients' average temperature on arrival of resuscitation team: pre‐hospital cooling group 35.9°C, hospital cooling group: 35.8°C Inclusion criteria:
Exclusion criteria:
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Interventions | Pre‐hospital cooling: 40 mL/kg and up to 2000 mL ice‐cold lactated Hartmann solution, given after resuscitation, n = 82 Control: in‐hospital cooling, n = 81 |
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Outcomes |
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Funding | Supported by the Australian National Health and Medical Research Committee | |
Declarations of interest | None | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐randomized and allocated in blocks of 10 (5 to pre‐hospital cooling and 5 to hospital cooling) to each intensive care paramedic unit rating |
Allocation concealment (selection bias) | Low risk | Opaque, sealed envelopes. The envelope allocation was computer‐randomized and allocated in blocks of 10 to each intensive care paramedic unit. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Treating ambulance and in‐hospital staff were not blinded |
Blinding of outcome assessment (detection bias) Good neurological outcome | Low risk | Before hospital discharge, conscious participants were evaluated by a rehabilitation physician who was unaware of the study allocation |
Blinding of outcome assessment (detection bias) Survival | Low risk | Lack of blinding of survival data considered 'low risk' |
Blinding of outcome assessment (detection bias) Adverse events | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomized participants analysed for primary outcome |
Selective reporting (reporting bias) | Low risk | All expected outcomes included |
Other bias | High risk |
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