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this study was suspended for futility
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy |
|
| Control | Active Comparator | 6 hours course of normobaric oxygen therapy via a face full mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normobaric oxygen therapy | Other | oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raymond Poincaré Hospital | Garches | 92380 | France |
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| ID | Term |
|---|---|
| D002249 | Carbon Monoxide Poisoning |
| ID | Term |
|---|---|
| D005739 | Gas Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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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 | 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 |
|
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 | 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 | any complications of hyperbaric oxygen therapy | at one month |