Shiozaki 1993.
| Methods | Randomised controlled trial, parallel group | |
| Participants |
Total number of participants: 33 Baseline characteristics: Therapeutic cooling Age: mean (SD) 35.3 (± 15.3) years Gender M/F: 6/10 Type of injury (closed/open): not stated No cooling Age: mean (SD) 35.4 (± 12.6) years Gender M/F: 10/7 Type of injury (closed/open): not stated Inclusion criteria: participants in whom ICP remained > 20 mmHg at 5 to 6 hours after induction of high‐dose barbiturate therapy, GCS on admission ≤ 8 Exclusion criteria: < 10 years, ICP controlled with high‐dose barbiturate therapy alone, ICP equal to MAP before start of study Country: Japan Setting: Department of Traumatology at Osaka University Hospital |
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| Interventions |
Therapeutic cooling Number of participants: 16 Method of cooling: surface cooling with water‐circulating blankets above and below the participant Target temperature: 33.5 to 34.5 ºC Time of cooling: no details Duration of cooling: 2 days or until it was considered not to be effective Rewarming details: slowly, core temperature was maintained between 35.5 to 36.5 ºC for 24 hours. If ICP increased > 20 mmHg during rewarming, participant was recooled to 34 ºC. If ICP remained < 20 mmHg for ≥ 24 hours, participants were rewarmed spontaneously to > 37 ºC with continuous infusion of barbiturates at 2 mg/kg to prevent shivering Site of temperature measurement: bladder No cooling Number of participants: 17 |
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| Outcomes | Outcomes measured in study: CPP, ICP, cerebral blood flow and AVDO₂, complications (to include pneumonia), mortality at 6 months, GOS at 6 months | |
| Notes |
Funding/declarations of interest: no details Study dates: May 1987 to April 1992 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants randomly divided into two groups; no additional details |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias): mortality | Low risk | Lack of blinding unlikely to influence performance for this outcome |
| Blinding of participants and personnel (performance bias): GOS | Unclear risk | Unclear if lack of blinding would influence performance for this outcome |
| Blinding of participants and personnel (performance bias): pneumonia | Unclear risk | Unclear if lack of blinding would influence performance for this outcome |
| Blinding of outcome assessment (detection bias): mortality; pneumonia | Low risk | No details; lack of outcome assessor blinding is unlikely to influence outcome data |
| Blinding of outcome assessment (detection bias): GOS | Unclear risk | No details |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data reported for pneumonia has losses due to death within 48 hours. However, we included total participant numbers in the review data |
| Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or pre‐published protocol not reported. Insufficient information to make judgement |
| Other bias | Low risk | No other sources of bias identified |