Rockswold 2010.
Methods | Randomised, unblinded trial to test the feasibility of proposed larger RCT to come. | |
Participants | Adult patients with acute traumatic brain injury (within 24 hrs) and GCS <9 admitted to a neurosurgical intensive care setting. | |
Interventions | Two control groups: Intensive neurosurgical care according to current guidelines of Brain Trauma Foundation and 100% oxygen at 1 ATA for 3 hours daily (normobaric arm in this study) and intensive neurosurgical care without extra oxygen (standard care arm). Experimental group: As above plus 100% oxygen at 1.5 ATA for one hour daily for three days. |
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Outcomes | Multiple measures of brain metabolism, including oxygenation, oxygen consumption, lactate etc. Also intracranial pressure (relevant for this review). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized, but no description of details: "Twenty‐six patients were randomised to the HBO2 group..." |
Allocation concealment (selection bias) | Low risk | Probably concealment at entry: "After study eligibility and a GCS score were established, informed consent was obtained from each participant. Randomiszation occurred immediately after consenting..." |
Blinding (performance bias and detection bias) All outcomes | High risk | No attempt at blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients entered are accounted for with only minor data loss. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported by intention to treat. |
Other bias | Low risk | No clear other bias. |