Wang 2005.
| Methods | Randomised controlled trial, parallel group | |
| Participants |
Total number of participants: 40 Baseline characteristics: Baseline characteristics table not reported. Study authors state "no obvious differences in patients' condition such as age, sex, the level of ICP as well as other therapy between two groups" Inclusion criteria: not reported. Severe brain injured participants with GCS ≤ 8 Exclusion criteria: not reported Country: China Setting: hospital |
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| Interventions |
Therapeutic cooling Number of participants: 20 Method of cooling: water‐circulating blankets placed above and below the body Target temperature: 33.5 to 34.5 °C Time of cooling: immediately Duration of cooling: 2 days Rewarming details: approximately 1 °C per day by continuous infusion of barbiturates (2 mg/kg/h) to prevent shivering Site of measurement: intracranial No cooling Number of participants: 20 Methods to maintain normothermia: barbiturates infused during initial 48 hours, followed by continuous infusion of barbiturates to prevent shivering Target temperature: 37 °C |
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| Outcomes | Outcomes measured in study: changes in cerebrospinal fluid, cytokines, GOS at 6 months | |
| Notes |
Funding/declarations of interest: not reported Study dates: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were described as "randomly divided" into groups. No additional details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias): GOS | Unclear risk | No details. Unclear if lack of blinding may influence performance |
| Blinding of outcome assessment (detection bias): GOS | Unclear risk | No details. Unclear if lack of blinding may influence outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or pre‐published protocol not reported. Insufficient information to make judgement |
| Other bias | Unclear risk | Limited detail in paper, not possible to judge other risks of bias |