Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

Carbon Monoxide Poisoning Clinical Trial

Official title:

Phase 3 Study of Hyperbaric Oxygen Therapy for Comatose Patients With Acute Domestic Carbon Monoxide Poisoning

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01099995
• Other study ID #: CO89-2
• Status: Terminated
• Phase: Phase 3
• First received: April 5, 2010
• Last updated: April 7, 2010
• Start date: October 1989
• Est. completion date: February 2000

Study information

• Verified date: April 2010
• Source: University of Versailles
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

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 two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: February 2000
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• patients older than 15 years of age

• admitted for domestic CO poisoning within 12 hours after the end of CO exposure

• initial coma, regardless of consciousness at hospital admission

• carboxyhemoglobin level at presentation greater than 10% or 5%, in smokers and non-smokers, respectively

Exclusion Criteria:

• poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke)

• suicide attempt

• pregnancy

• contraindications to HBO (circulatory collapse or pneumothorax)

• technical obstacles to HBO

• non domestic CO poisoning

• difficulty in determining whether the patient experienced initial loss of consciousness or initial coma

• consent refusal

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carbon Monoxide Poisoning
• Poisoning

Intervention

Other:
• Hyperbaric oxygen therapy
one dive at 2 absolute atmosphere (1-hour plateau) with 30 min time for compression and decompression - oxygen was delivered via a full face mask at high concentration to achieve a 100% inspired fraction of oxygen or via mechanical ventilation
• hyperbaric oxygen therapy
two dives at 2 absolute atmosphere (1-hour plateau) with 30 min of compression and 30 min of decompression - oxygen being delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation

Locations

Country	Name	City	State
France	Raymond Poincaré Hospital	GArches

Sponsors (2)

Lead Sponsor	Collaborator
University of Versailles	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete recovery	Complete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).	at one month	No
Secondary	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.	at one month	Yes
Secondary	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.	at one month	Yes
Secondary	the difference in carboxyhemoglobin levels before/after treatment completion	the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion	at 12 hours from randomization	No
Secondary	serious adverse events	any complication of hyperbaric oxygen therapy	at one month	Yes