Bernard 2002.
| Methods | Randomization: pre‐hospital | |
| Participants | Total number of participants 77, mean age 66 years, 33% female Out‐of‐hospital cardiac arrest of cardiac cause, ventricular fibrillation as first cardiac rhythm, comatose after resuscitation Participating sites: Australian university and community hospitals Multi‐centre: yes Language: English Allocation concealment: not applicable (odd and even days) Outcome assessor blind: yes Intention‐to‐treat analysis: yes Groups comparable: more females and more bystander CPR in hypothermia group Follow‐up > 80% of randomly assigned participants: yes |
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| Interventions | Therapeutic hypothermia vs standard pre‐hospital treatment protocols and intensive care treatment Means of cooling: ice packs placed around head, neck, torso and limbs Cooling rate: time from ROSC to target temperature: 2 hours Target temperature: 33°C Duration of cooling: 12 hours after target temperature was reached Rewarming: passive after 12 hours, active after 18 hours |
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| Outcomes | Survival with good neurological function to be sent home or to a rehabilitation facility at discharge In‐hospital death Haemodynamic, biochemical and haematological effects of hypothermia For IPD analysis, best ever reached CPC during hospital stay and CPC discharge provided |
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| Notes | Randomization: odd and even days | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Odd and even days |
| Allocation concealment (selection bias) | High risk | Odd and even days |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Treating personnel not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up |
| Other bias | Low risk | No other major biases seen |
| Funding | Unclear risk | No information provided |
| Blinding of outcome assessment (detection bias) Good neurologic outcome All outcomes | Low risk | Outcome assessment blinded |
| Blinding of outcome assessment (detection bias) Survivial Survival | Low risk | Outcome assessment blinded |