Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Thorough description provided in brief summary.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy | No Intervention | Standard emergency department evaluation and treatment for headache | |
| Medical Air | Placebo Comparator | Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache |
|
| Oxygen | Experimental | Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Air | Biological | Compressed medical air |
| |
| Oxygen |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relief (Min) | 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. | study duration |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in the Emergency Department(Min) | 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. | Study duration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boris D Veysman, M.D. | Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital Emergency Department | New Brunswick | New Jersey | 08801 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Therapy | Standard emergency department evaluation and treatment for headache |
| FG001 | Air at 15L/Min | Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache |
| FG002 | Oxygen | Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Therapy | Standard emergency department evaluation and treatment for headache |
| BG001 | Air at 15L/Min | Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Length of Stay in the Emergency Department(Min) | 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. | Posted | Aug 2011 | Mean | Standard Deviation | Minutes | Study duration |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Therapy | Standard emergency department evaluation and treatment for headache |
Not provided
Not provided
Limited number of subjects due to difficulty with recruitment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Boris Veysman | UMDNJ | 732-235-8717 | veysmabo@umdnj.edu |
Not provided
| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000388 | Air |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
Medical Oxygen |
|
| BG002 | Oxygen | Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Oxygen at 15 L / Min |
Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache |
|
|
| Primary | Time to Relief (Min) | 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. | Posted | Aug 2011 | Mean | Standard Deviation | Minutes | study duration |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Air at 15L/Min | Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache | 0 | 29 | 0 | 29 |
| EG002 | Oxygen | Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache | 0 | 36 | 0 | 36 |
Not provided
Not provided
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |