A Phase 3 interventional study of normobaric oxygen therapy and Hyperbaric oxygen therapy in Carbon Monoxide Poisoning, sponsored by University of Versailles. Terminated at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2010-04-09.
Sponsored by University of Versailles · Phase 3, Interventional, and Treatment
Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.
43 studies on the registry are indexed under Carbon Monoxide Poisoning; 8 are open to participants now.
This study's enrollment of 179 is above the median of 75 across 15 interventional studies indexed under Carbon Monoxide Poisoning.
Browse Carbon Monoxide Poisoning studies →University of Versailles is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy
Other: Hyperbaric oxygen therapy
6 hours course of normobaric oxygen therapy via a face full mask
Other: normobaric oxygen therapy
oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction
Hyperbaric oxygen therapy was delivered in a hyperbaric chamber, pressurized at 2 absolute atmosphere (1 hour plateau) and the patient breathed high oxygen concentration via a full face mask followed by 4 hours of normobaric oxygen therapy
full recovery
Full recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).
Time frame: at one month
persistent neurological sequels
Neurological sequels were considered persistent (PNS) if they were present both at hospital discharge and at one-month evaluation, regardless of the type of manifestation
Time frame: at one month
delayed neurological sequels
Delayed neurological sequelae (DNS) were any neurological manifestations that appeared between hospital discharge and one-month evaluation, regardless of their severity. Patients with DNS were those considered fully recovered at hospital discharge but with neurological manifestations at one-month evaluation
Time frame: at one month
variations in carboxyhemoglobin levels
the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion
Time frame: at 12 hours from randomization
serious adverse events
any complications of hyperbaric oxygen therapy
Time frame: at one month
This study is terminated, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Versailles