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. 2016 Mar 15;2016(3):CD010570. doi: 10.1002/14651858.CD010570.pub2

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:
  • out‐of‐hospital cardiac arrest

  • cause of cardiac arrest: any

  • primary rhythm: asystole or PEA

  • return of spontaneous circulation with a systolic blood pressure 90 mmHg (with epinephrine infusion if needed)

  • total cardiac arrest time > 10 mins

  • age older than 14 years

  • intravenous access available


Exclusion criteria:
  • dependent on others for activities of daily living

  • already hypothermic (temperature < 34°C)

  • females who were obviously pregnant

  • cardiac arrest after trauma

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
Outcomes
  • Favourable outcome defined as discharge either to home or to a rehabilitation facility

  • Core (bladder or oesophageal) temperatures at hospital arrival, the development of pre‐hospital pulmonary oedema, and recurrent pre‐hospital cardiac arrest after enrolment

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
  • From 309 eligible participants 146 were not enrolled; no reasons could be determined.

  • Of 82 participants assigned to pre‐hospital cooling, only 36 (44%) of all participants in the intervention group received the full intervention of 2 L; 13 participants (16%) received no intervention at all.

  • Participants in the intervention group rewarmed after admission to hospital, which reduced the actual temperature difference between the 2 groups.

  • The prespecified target temperature of 33°C could not be reached for a relevant number of participants. The mean target temperature presented for both groups was around 34°C, which implies that 50% of all participants did not reach the 32°C to 34°C recommended by the then current guidelines.