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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856232
• Other study ID #: 0220080056
• Status: Completed
• Phase: N/A
• First received: March 4, 2009
• Last updated: March 22, 2013
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: March 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Description:

Thorough description provided in brief summary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 _____

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache

Intervention

Biological:
• Medical Air
Compressed medical air
• Oxygen
Medical Oxygen

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital Emergency Department	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	study duration	No
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.	Study duration	No