Research Reports - 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

J Neurosurg. 2013 Mar 19

Rockswold SB, Rockswold GL, Zaun DA, Liu J

Object Preclinical and clinical investigations indicate that the positive effect
of hyperbaric oxygen (HBO2) for severe traumatic brain injury (TBI) occurs after
rather than during treatment. The brain appears better able to use baseline O2
levels following HBO2 treatments. In this study, the authors evaluate the
combination of HBO2 and normobaric hyperoxia (NBH) as a single treatment. Methods
Forty-two patients who sustained severe TBI (mean Glasgow Coma Scale [GCS] score
5.7) were prospectively randomized within 24 hours of injury to either: 1)
combined HBO2/NBH (60 minutes of HBO2 at 1.5 atmospheres absolute [ATA] followed
by NBH, 3 hours of 100% fraction of inspired oxygen [FiO2] at 1.0 ATA) or 2)
control, standard care. Treatments occurred once every 24 hours for 3 consecutive
days. Intracranial pressure, surrogate markers for cerebral metabolism, and O2
toxicity were monitored. Clinical outcome was assessed at 6 months using the
sliding dichotomized Glasgow Outcome Scale (GOS) score. Mixed-effects linear
modeling was used to statistically test differences between the treatment and
control groups. Functional outcome and mortality rates were compared using
chi-square tests. Results There were no significant differences in demographic
characteristics between the 2 groups. In comparison with values in the control
group, brain tissue partial pressure of O2 (PO2) levels were significantly
increased during and following combined HBO2/NBH treatments in both the
noninjured and pericontusional brain (p < 0.0001). Microdialysate
lactate/pyruvate ratios were significantly decreased in the noninjured brain in
the combined HBO2/NBH group as compared with controls (p < 0.0078). The combined
HBO2/NBH group's intracranial pressure values were significantly lower than those
of the control group during treatment, and the improvement continued until the
next treatment session (p < 0.0006). The combined HBO2/NBH group's levels of
microdialysate glycerol were significantly lower than those of the control group
in both noninjured and pericontusional brain (p < 0.001). The combined HBO2/NBH
group's level of CSF F2-isoprostane was decreased at 6 hours after treatment as
compared with that of controls, but the difference did not quite reach
statistical significance (p = 0.0692). There was an absolute 26% reduction in
mortality for the combined HBO2/NBH group (p = 0.048) and an absolute 36%
improvement in favorable outcome using the sliding dichotomized GOS (p = 0.024)
as compared with the control group. Conclusions In this Phase II clinical trial,
in comparison with standard care (control treatment) combined HBO2/NBH treatments
significantly improved markers of oxidative metabolism in relatively uninjured
brain as well as pericontusional tissue, reduced intracranial hypertension, and
demonstrated improvement in markers of cerebral toxicity. There was significant
reduction in mortality and improved favorable outcome as measured by GOS. The
combination of HBO2 and NBH therapy appears to have potential therapeutic
efficacy as compared with the 2 treatments in isolation.

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