A prospective, randomized Phase II clinical trial... (2013 study) Skip to main content
RCT Journal of neurosurgery 2013

A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury.

Rockswold SB, Rockswold GL, Zaun DA, Liu J, Journal of neurosurgery, 2013

Tier 2, Indexed

Automatically imported from PubMed based on relevance criteria.

Summary

What Researchers Did

Researchers randomly assigned 42 people with severe traumatic brain injury to receive either combined hyperbaric and normobaric oxygen therapy or standard care, then tracked brain chemistry, pressure, and recovery for six months.

What They Found

This randomized Phase II trial found that combined therapy, hyperbaric oxygen (60 minutes at 1.5 ATA) followed by normobaric hyperoxia (3 hours of 100% oxygen at 1.0 ATA), given once daily for 3 consecutive days, was associated with a 26% absolute reduction in mortality (p = 0.048) and a 36% absolute improvement in favorable outcomes on the Glasgow Outcome Scale (p = 0.024) compared to standard care. Brain tissue oxygen levels rose significantly during and after treatment (p less than 0.0001), and the treated group also showed significantly lower intracranial pressure (p less than 0.0006), lower microdialysate glycerol (p less than 0.001), and a lower lactate/pyruvate ratio in noninjured brain tissue (p = 0.0078). A marker of oxidative stress (CSF F2-isoprostane) was lower in the treated group at 6 hours but did not quite reach statistical significance (p = 0.0692).

Canadian Relevance

No direct Canadian connection identified.

Study Limitations

This was a small, single Phase II trial of 42 patients, and one of its measured outcomes, the reduction in CSF F2-isoprostane, did not reach statistical significance (p = 0.0692).

This plain-language summary was generated with AI assistance from the study's abstract; it has not been individually reviewed by a clinician. Always consult the source study and a qualified healthcare professional. See our editorial policy.

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Study Details

Study Type RCT
Category Neurological
Source Pubmed
PubMed ID 23510092
Year Published 2013
Journal Journal of neurosurgery
MeSH Terms Adult; Biomarkers; Brain; Brain Injuries; Combined Modality Therapy; Female; Glasgow Outcome Scale; Humans; Hyperbaric Oxygenation; Intracranial Hypertension; Intracranial Pressure; Linear Models; Male; Oxygen; Prospective Studies

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Disclaimer: This study summary is provided for informational and educational purposes only. It does not constitute medical advice. The information presented reflects the findings of the original research authors and may not represent the views of Canada Hyperbarics. Always consult a qualified healthcare professional before making treatment decisions.

Last updated: April 1, 2026 | Reviewed by: Canada Hyperbarics Editorial Team | Editorial process | Research sources | Counts & methodology