Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning

Carbon Monoxide Poisoning Clinical Trial

Official title:

Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01100515
• Other study ID #: CO89
• Status: Terminated
• Phase: Phase 3
• First received: April 5, 2010
• Last updated: April 8, 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 179
• 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.

• had transient loss of consciousness (syncope, malaise)

• carboxyhemoglobin level at presentation >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

• coma

• 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:
• 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
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

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	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).	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	variations in carboxyhemoglobin levels	the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion	at 12 hours from randomization	No
Secondary	serious adverse events	any complications of hyperbaric oxygen therapy	at one month	Yes