- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01100515
Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning
April 8, 2010 updated by: University of Versailles
Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
179
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Garches, France, 92380
- Raymond Poincaré Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental arm
Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric 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
|
Active Comparator: Control
6 hours course of normobaric oxygen therapy via a face full mask
|
oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
full recovery
Time Frame: at one month
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
persistent neurological sequels
Time Frame: at one month
|
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
|
delayed neurological sequels
Time Frame: at one month
|
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
|
variations in carboxyhemoglobin levels
Time Frame: at 12 hours from randomization
|
the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion
|
at 12 hours from randomization
|
serious adverse events
Time Frame: at one month
|
any complications of hyperbaric oxygen therapy
|
at one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1989
Primary Completion (Actual)
January 1, 2000
Study Completion (Actual)
February 1, 2000
Study Registration Dates
First Submitted
April 5, 2010
First Submitted That Met QC Criteria
April 8, 2010
First Posted (Estimate)
April 9, 2010
Study Record Updates
Last Update Posted (Estimate)
April 9, 2010
Last Update Submitted That Met QC Criteria
April 8, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO89
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carbon Monoxide Poisoning
-
Rigshospitalet, DenmarkCompletedCarbon Monoxide Poisoning From Fire AccidentsDenmark
-
Johns Hopkins Bloomberg School of Public HealthBrown University; National Institutes of Health (NIH); Universidad Peruana Cayetano... and other collaboratorsCompletedRespiratory Conditions Due to Other External Agents | Poisoning by Carbon Monoxide From Domestic FuelsKenya, Nepal, Peru
-
Nonin Medical, IncCompleted
-
Paul G. Harch, M.D.Harch Hyperbaric Research FoundationUnknownNeuropsychiatric Sequelae of Carbon Monoxide PoisoningUnited States
-
Liaocheng People's HospitalUnknownDelayed Encephalopathy After Carbon Monoxide PoisoningChina
-
St George's, University of LondonUniversity College, LondonUnknownCarbon Monoxide Poisoning
-
University Hospital, ToursCompletedCarbon Monoxide PoisoningFrance
-
Intermountain Health Care, Inc.Recruiting
-
Intermountain Health Care, Inc.Enrolling by invitation
-
Ankara City Hospital BilkentRecruitingCarbon Monoxide PoisoningTurkey
Clinical Trials on Hyperbaric oxygen therapy
-
National Baromedical ServicesMayo Clinic; Dartmouth-Hitchcock Medical Center; Eastern Virginia Medical School and other collaboratorsCompletedCarcinoma, Squamous Cell | Cancer of the Head and NeckUnited States
-
Bayside HealthNational Health and Medical Research Council, Australia; Monash UniversityCompletedTibial Fracture | Soft Tissue InjuryAustralia, Sweden, Chile, United States, Austria, India, Italy, Portugal, Czechia
-
Louisiana State University Health Sciences Center...U.S. Army Medical Research and Development CommandUnknownTraumatic Brain Injury | Post-Concussion SyndromeUnited States
-
Omar AljitawiCompleted
-
University of British ColumbiaUnknown
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
St. Joseph's Healthcare HamiltonUniversity Health Network, Toronto; Judy Dan Research and Treatment Centre...CompletedDiabetes Mellitus | Chronic Ulcers of the Lower LimbCanada
-
University of VersaillesAssistance Publique - Hôpitaux de ParisTerminatedCarbon Monoxide PoisoningFrance
-
UMC UtrechtThe Netherlands Cancer InstituteCompletedBreast Cancer | Radiation ToxicityNetherlands
-
Assaf-Harofeh Medical CenterUnknownChronic Renal FailureIsrael