HeadacheNCT00856232
Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
A study testing Medical Air and Oxygen in people with Headache, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Headache
- What is being tested?
- Medical Air and Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED.
Who cannot join
- patients who need immediate oxygen after triage: Recent fire or carbon monoxide exposure_______ O2 saturation 94% or less on room air on triage vitals ______ patient arrives on supplemental oxygen_______ patient reports shortness of breath_______
- patients in whom 100% oxygen is contraindicated, potentially undesirable, or controversial: history of COPD_______ possible cardiac ischemia (mouth / jaw / neck / shoulder / chest / abdomen pain or pressure)_______ possible stroke (new focal weakness or numbness, speech, hearing or vision deficit, bowel or bladder incontinence or retention)_____
- patients unable to tolerate the gas treatment: patient not able to tolerate a face mask_______ patient requests immediate treatment with another preferred therapeutic agent_______
- treating physician or nurse request to discontinue the study at any point_______
- patients who have diminished decision-making capacity history of mental retardation or pervasive developmental disorder_______ patient not awake and alert_______ patient not oriented to self, month and year, and current location_______ patient unwilling or unable to fully participate in the research associate interview and consent process_______
- patients who are at risk for intracranial hemorrhage history of intracranial aneurythm, hemorrhage, surgery, or tumor_______ current headache began after trauma_______ current headache began after using elicit drugs_______
Show all 11Show fewer
- patients who are at high risk for intracranial infection fever > 100.4 F on triage vitals_______ complaining of recent onset neck stiffness_______
- patients who are at high risk for extracranial head pathology ear pain or drainage_______ tooth or gum pain_______ headache localized to a skin lesion on the head______
- patient is potentially critically ill active bleeding from any source_______ heart rate <60 or >130 on triage vitals_______ systolic blood pressure <90 or >180 on triage vitals_______ respiratory rate < 10 or >30 on triage vitals_______
- patient is younger than 21_______
- patients who know or suspect they are pregnant _____
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital Emergency Department
New Brunswick, New Jersey, 08801
About this study
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.
Read the detailed description
Thorough description provided in brief summary.
- Conditions
- Headache
- Being tested
- Medical Air, Oxygen
- Keywords
- Headache, Cephalgia, Migraine
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical AirBiological
Compressed medical air
OxygenBiological
Medical Oxygen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Medical Air |
| Oxygen | Experimental | Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache Receives: Biological: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: study duration
Secondary outcomes (1)
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.
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rwjms-ed, Rutgers, The State University of New Jersey
- Investigators
- Boris D Veysman, M.D., Principal investigator, Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856232
- Sponsor's protocol ID
- 0220080056
- Status last verified
- Mar 2016
- First submitted
- 4 Mar 2009
- Last updated
- 21 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
- ClinicalTrials.gov ID
- NCT00856232
- Acronym / sponsor ID
- 0220080056
- Conditions
- Headache
- Keywords
- Headache, Cephalgia, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Posted 3 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thorough description provided in brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | No intervention | –Standard emergency department evaluation and treatment for headache |
| Medical Air | Placebo comparator | Biological: Medical AirAir inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache |
| Oxygen | Experimental | Biological: OxygenOxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED.
Key exclusion criteria (11 listed)
- patients who need immediate oxygen after triage: Recent fire or carbon monoxide exposure_______ O2 saturation 94% or less on room air on triage vitals ______ patient arrives on supplemental oxygen_______ patient reports shortness of breath_______
- patients in whom 100% oxygen is contraindicated, potentially undesirable, or controversial: history of COPD_______ possible cardiac ischemia (mouth / jaw / neck / shoulder / chest / abdomen pain or pressure)_______ possible stroke (new focal weakness or numbness, speech, hearing or vision deficit, bowel or bladder incontinence or retention)_____
- patients unable to tolerate the gas treatment: patient not able to tolerate a face mask_______ patient requests immediate treatment with another preferred therapeutic agent_______
- treating physician or nurse request to discontinue the study at any point_______
- patients who have diminished decision-making capacity history of mental retardation or pervasive developmental disorder_______ patient not awake and alert_______ patient not oriented to self, month and year, and current location_______ patient unwilling or unable to fully participate in the research associate interview and consent process_______
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical AirCompressed medical air | Biological | Medical Air |
| OxygenMedical Oxygen | Biological | Oxygen |
Primary outcome
Time to Relief (Min)
Time frame: study duration
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.
1 secondary outcome
Length of Stay in the Emergency Department(Min)
Time frame: Study duration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris D Veysman, M.D. principal investigator
Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Air and Oxygen in people with Headache, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Relief (Min) (time frame: study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.