Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-31 @ 7:49 AM
Study NCT ID:
NCT00856232
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2009-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Study Overview
Official Title:
Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: