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| Name | Class |
|---|---|
| Deseret Foundation | OTHER |
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This randomized trial will investigate important clinical outcomes of patients with acute carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen treatments.
All patients presenting with acute carbon monoxide poisoning will receive one hyperbaric oxygen treatment (barring contraindications for hyperbaric oxygen therapy). After this treatment, eligible patients who provide consent will be randomly allocated to receive two sham sessions, or two additional hyperbaric oxygen sessions administered in a double-blind fashion.
Outcome measures will be administered at 6 weeks and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen (HBO2) - 3 sessions | Active Comparator | Subjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning. |
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| Hyperbaric Oxygen (HBO2) - 1 session | Sham Comparator | Subjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen (HBO2) - 3 sessions | Combination Product | Before patients are offered an opportunity to participate in this study, they will receive a single hyperbaric oxygen session. During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing. For the second and third hyperbaric oxygen sessions, the subject will breathe 100% oxygen delivered at 2 atm abs for 90 minutes with two 5-minute air breathing periods. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-week cognitive sequelae | Presence of cognitive sequelae at 6-week follow-up | 6 weeks after poisoning |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological examination | Presence of neurological abnormalities | 6 weeks and 6 months after poisoning |
| Depression, anxiety or post-traumatic stress syndrome | Presence of depression, anxiety, or PTSD symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindell K Weaver, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain LDS Hospital | Salt Lake City | Utah | 84143 | United States | ||
| Intermountain Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12362006 | Background | Weaver LK, Hopkins RO, Chan KJ, Churchill S, Elliott CG, Clemmer TP, Orme JF Jr, Thomas FO, Morris AH. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2002 Oct 3;347(14):1057-67. doi: 10.1056/NEJMoa013121. |
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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 |
|---|---|
| D010108 | Oxyhemoglobins |
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D006454 | Hemoglobins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Hyperbaric Oxygen (HBO2) - 1 session | Combination Product | During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing. The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods. |
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| 6 weeks and 6 months after poisoning |
| Vocational assessment | Results of vocational testing | 6 weeks and 6 months after poisoning |
| Patient self-reports of CO-related problems | Participant-reported outcome | 6 weeks and 6 months |
| Salt Lake City |
| Utah |
| 84157-7000 |
| United States |
| D005914 |
| Globins |
| D006420 | Hemeproteins |
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |