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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 23, 2007 | ||||||||
| Last Updated Date | April 23, 2007 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
6-week cognitive sequelae | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning | ||||||||
| Official Title ICMJE | Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Carbon Monoxide Poisoning | ||||||||
| Intervention ICMJE | Procedure: Hyperbaric oxygen therapy (HBO2) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | May 2009 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 79 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00465855 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 1002700 | ||||||||
| Study Sponsor ICMJE | Intermountain Health Care, Inc. | ||||||||
| Collaborators ICMJE | Deseret Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | Intermountain Health Care, Inc. | ||||||||
| Verification Date | April 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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