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Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department

Primary Purpose

Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Air
Oxygen
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring Headache, Cephalgia, Migraine

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED.

Exclusion Criteria:

  • 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_______
  • 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 _____

Sites / Locations

  • Robert Wood Johnson University Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

Standard therapy

Medical Air

Oxygen

Arm Description

Standard emergency department evaluation and treatment for headache

Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache

Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 4, 2009
Last Updated
March 23, 2016
Sponsor
University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00856232
Brief Title
Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
Official Title
Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Dentistry of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Thorough description provided in brief summary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Headache, Cephalgia, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
Standard emergency department evaluation and treatment for headache
Arm Title
Medical Air
Arm Type
Placebo Comparator
Arm Description
Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
Arm Title
Oxygen
Arm Type
Experimental
Arm Description
Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
Intervention Type
Biological
Intervention Name(s)
Medical Air
Intervention Description
Compressed medical air
Intervention Type
Biological
Intervention Name(s)
Oxygen
Intervention Description
Medical Oxygen
Primary Outcome Measure Information:
Title
Time to Relief (Min)
Description
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.
Time Frame
study duration
Secondary Outcome Measure Information:
Title
Length of Stay in the Emergency Department(Min)
Description
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.
Time Frame
Study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED. Exclusion Criteria: 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_______ 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 _____
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris D Veysman, M.D.
Organizational Affiliation
Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Wood Johnson University Hospital Emergency Department
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08801
Country
United States

12. IPD Sharing Statement

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Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department

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