A randomized trial of one versus three hyperbaric oxygen sessions for acute carbon monoxide poisoning
Introduction: Hyperbaric oxygen (HBO2) improves outcome in patients with acute carbon monoxide (CO) poisoning, but optimal dose/timing are unknown. In this double-blind, sham-controlled randomized trial, we compared neuropsychological sequelae at six weeks and six months in patients receiving three HBO2 sessions or one HBO2 session and two sham chamber sessions after acute CO poisoning.
Methods: After completing one HBO2 session (3.0 ATA, 60 minutes, 2.0 ATA, 65 minutes), CO-poisoned patients were randomized (1:1): two sham chamber sessions (1 ATA air, 120 minutes) or two additional HBO2 sessions (2.0 ATA, 90 minutes at pressure, 120 minutes in chamber) completed within 24 hours. Eligible patients were <24 hours from accidental poisoning, English-speaking, and not intubated. We planned 150 participants.
Results: The study was stopped early for enrollment futility. From 2006 to 2016, we screened 395 patients: 136 were deemed eligible to participate, and 75 signed informed consent. Two were later withdrawn
for past brain injury/PTSD (one sham, one HBO2), and one for performance validity (sham). Of the 72 analyzed, mean age was 42 ± 15 years, 40 (56%) were male, 20 (28%) had loss of consciousness, and mean initial carboxyhemoglobin was 22 ± 9%. The rate of six-week neuropsychological sequelae was 50% in the one-HBO2 session group and 55% in the three-HBO2 sessions group (p = 0.80), and at six months was 42% versus 46%, respectively (p = 0.76).
Conclusions: There was no difference in the rate of neuropsychological sequelae in those who received three HBO2 sessions and those who received one HBO2 sessions and two sham sessions. The higher rate of neuropsychological sequelae compared to an earlier study may be due to neuropsychological test-retest effects or previously identified risk factors for cognitive sequelae (age, duration of poisoning, cerebellar dysfunction). This study’s rates of cognitive difficulties, affective complaints, and other symptoms suggest brain injury after CO poisoning is common.
Keywords: Carbon monoxide poisoning; hyperbaric oxygenation; clinical trial