Smrcka 2005.
| Methods | Randomised controlled trial, parallel group | |
| Participants |
Total number of participants: 72 Baseline characteristics: Baseline characteristics not reported by group. Mean age 41 years; gender M/F: 51/21 Inclusion criteria: Severe brain injury GCS < 8 Exclusion criteria: patients > 60 years of age, those with severe primary brain damage with no possibility of survival (bilateral mydriasis, no reflexes above C1) Country: Czech Republic Setting: hospital |
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| Interventions |
Therapeutic cooling Number of participants: 35 Method of cooling: surface cooling Target temperature: 34 °C Time of cooling: within 15 hours of injury Duration of cooling: to reach 34 °C within 3 hours of cooling for 72 hours Rewarming details: passively warmed after 72 hours Site of measurement: urinary bladder No cooling Number of participants: 37 |
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| Outcomes | Outcomes measured in study: ICP, CCP, jugular bulb oxygen saturation, GOS at 6 months (to include mortality at 6 months) | |
| Notes |
Funding/declarations of interest: supported by grant from the Internal Grant Agency of the Czech Ministry of Health Study dates: 2001 to 2003 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as randomised; 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 likely to 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 | No apparent losses |
| 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 apparent sources of bias |