Skip to main content
. 2012 Dec 12;2012(12):CD004609. doi: 10.1002/14651858.CD004609.pub3

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.
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.