Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
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| Tracking Information | |||||
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| First Received Date ICMJE | March 4, 2009 | ||||
| Last Updated Date | March 22, 2013 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Time to Relief (Min) [ Time Frame: study duration ] [ Designated as safety issue: No ] Time to relief is a measure of time reported by a stopwatch the patients were provided in the beginning of the study, which showed elapsed time in minutes for patients to perceive that they no longer had a headache. |
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| Original Primary Outcome Measures ICMJE |
Efficacy of headache relief from oxygen compared to air inhalation (placebo) or no treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00856232 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Length of Stay in the Emergency Department(Min) [ Time Frame: Study duration ] [ Designated as safety issue: No ] Length of stay was reported as time elapsed in minutes from subject's arrival as a patient to the Emergency Department to patient's discharge from the Emergency Department. |
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| Original Secondary Outcome Measures ICMJE |
Faster hospital discharge and less resource utilization for patients receiving oxygen therapy. [ Time Frame: 2 yrs ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department | ||||
| Official Title ICMJE | Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department | ||||
| Brief Summary | This study will randomly assign emergency department patients seeking treatment for a headache to one of three groups. The first group will receive standard emergency care as determined by the treating physician, the second group will breathe high flow air by facemask for 15 minutes, and the third group will breathe high flow oxygen by face mask for 15 minutes. The patients will be questioned in the beginning of their treatment and at 2, 5, 10, 15 and 30 minutes after it's begun about the intensity of their headache and how much relief they are experiencing from their treatment. Concentration of carbon dioxide exhaled by patients will also be recorded at 0, 2, 5, 10, 15 and 30 minutes. After fifteen minutes, the patients in groups 2 and 3 will continue with standard emergency care, which can include any treatment their physician sees fit. Patients in all three groups will receive a stopwatch in the beginning of their emergency department visit and record the total extent of time their headache will take to resolve. |
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| Detailed Description | Thorough description provided in brief summary. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Headache | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 91 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00856232 | ||||
| Other Study ID Numbers ICMJE | 0220080056 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | rwjms-ed, University of Medicine and Dentistry New Jersey | ||||
| Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Medicine and Dentistry New Jersey | ||||
| Verification Date | March 2013 | ||||
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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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