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the study was halted after the first interim analysis as there were significantly more patients who recovered at one month in the control arm
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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One HBO session | Active Comparator | hyperbaric oxygen therapy one dive at 2 absolute atmosphere (1-hour plateau) - oxygen was delivered via a full face mask - followed by 4 hours of normobaric oxygen therapy |
|
| 2 HBO sessions | Experimental | Two sessions of hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) with oxygen delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen therapy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| delayed neurological sequels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Djillali Annane, MD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Jean Claude Raphael | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raymond Poincaré Hospital | Garches | 92380 | France |
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| ID | Term |
|---|---|
| D002249 | Carbon Monoxide Poisoning |
| D003128 | Coma |
| ID | Term |
|---|---|
| D005739 | Gas Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014474 | Unconsciousness |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| hyperbaric oxygen therapy | Other | 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 |
|
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 |
| 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 |
| serious adverse events | any complication of hyperbaric oxygen therapy | at one month |
| D003244 |
| Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |