Rockswold3
Combined hyperbaric and normobaric oxygen therapy (HBOT/NBO) improves outcome of severe traumatic brain injury.
Clinical bottom line:
| # Combined HBO2/NBO therapy improved clinical outcome in traumatic brain injury. # Combined HBO2/NBO therapy significantly reduced intracranial pressure. |
- Citation/s:
Rockswold SB, Rockswold GL, Zaun DA, Liu J. 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. Journal of Neurosurgery 2013; 118: 1317-1328
Lead author's name and fax: Rockswold Sarah B.: [| gaylan.rockswold@hcmed.org]
- Three-part Clinical Question: In patients with severe TBI, does combined HBO2 and NBO improve outcome when compared to standard care.
Search Terms: traumatic brain injury; cerebral metabolism; intracranial pressure
- The Study: Non-blinded randomized controlled trial with intention-to-treat.
- The Study Patients: Sustained severe traumatic brain injury (TBI) with GCS < 9 after resuscitation or mild to moderate TBI when deteriorated to GCS < 9 within 48 hours.
- Control group (N = 22; 21 analyzed): Intensive neurosurgical care paralleling the Brain Trauma Foundation Guidelines including stabilization with early intubation, surgical evacuation of significant hematomas, continuous monitoring of intra-cranial pressure (ICP), treatment of ICP > 15 mmHg and phenytoin.
- Experimental group (N = 20; 19 analyzed): As above, plus, HBO2: 100% oxygen at 1.5 ATA for 60 min followed by 100% at 1 ATA (NBH) for 180 min. 3 consecutive treatments (1 per 24 hours).
- The Evidence:
| Outcome | Time to Outcome | Control group | HBO group | Relative risk reduction | Absolute risk reduction | NNT |
| Favourable clinical outcome (n21 for control/n19 for exp. gr.) |
6 months | 0.364 | 0.700 | 92% | 0.34 | 3 |
| ^ | 95% CI: | 14% to 170% | 0.05 to 0.62 | 2 to 19 |
| Non-Event Outcomes | Time to outcome/s | Control group (n22) |
HBO group (N20) |
P-value |
| Mean peri-contusional tissue pO2 (mmHg) as a proportion of pre-treatment value | 2 hours | 100% | 150 % | < 0.0001 |
| Relative mean difference in intracranial pressure before and after treatment (mmHg) | Immediately after treatment | 95% | 80% | 0.0019 |
- Comments:
1. The power of the study is limited by the small number of patients. 2. Absolute mean values not given for brain tissue oxygen pressure (PtO2) or intracranial pressure (ICP), instead mean differences, presumably in percentages, are given. 3. Exact times of measurements of ICP are not stated. 4. Mortality rate said to be significantly lower in the experimental (16%) vs the control group (42%) (p = 0.048), but may be considered not significant. 5. Two patients (one for each arm) were lost and not included in the clinical outcome or mortality analysis.
- Appraised by: Thorben Selm, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital, NSW, Sydney, Australia; 17th March 2015
- Email: m.bennett@unsw.edu.au
- Kill or Update By: November 2021
