Kim 2007.
Methods | Parallel‐group, randomized trial, November 2004 to February 2006, multicentre study | |
Participants | Total number of participants 125, mean age 66 years, 30% female, patients' average temperature at randomization: pre‐hospital cooling group 35.8°C, hospital cooling group: 35.5°C Inclusion criteria:
Exclusion criteria:
|
|
Interventions | Pre‐hospital induction of cooling (32°C to 34°C): up to 2 L of 4°C normal saline after resuscitation Control: standard care with and without hypothermia |
|
Outcomes | Primary:
Secondary:
|
|
Funding | This work was supported by a grant from the Medic One Foundation and National Institutes of Health grant HL04346 (F.K.) | |
Declarations of interest | None | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "...balanced blocks of 4" |
Allocation concealment (selection bias) | Low risk | Paramedics called the emergency department physician at Harborview Medical Center to verify eligibility and to learn treatment assignment. The emergency room physician opened sequentially numbered envelopes that randomized participants to either receive or not receive cooling. |
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 | High risk | Study personnel during data collection and analysis could not be entirely unaware of treatment assignment |
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) | Unclear risk | Of participants discharged alive, only severe neurological deficit was reported, but not in detail (neurological scores missing) |
Other bias | High risk |
|