Trial Outcomes & Findings for Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department (NCT NCT00856232)

NCT ID: NCT00856232

Last Updated: 2016-04-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 91 participants
• Primary outcome timeframe: study duration
• Results posted on: 2016-04-21

Participant Flow

Participant milestones

Measure	Standard Therapy Standard emergency department evaluation and treatment for headache	Air at 15L/Min Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache	Oxygen Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
Overall Study STARTED	26	29	36
Overall Study COMPLETED	26	29	36
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard Therapy n=26 Participants Standard emergency department evaluation and treatment for headache	Air at 15L/Min n=29 Participants Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache	Oxygen n=36 Participants Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache	Total n=91 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Age, Categorical Between 18 and 65 years	NA participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	NA participants n=4 Participants
Age, Categorical >=65 years	NA participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	NA participants n=4 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Region of Enrollment United States	26 participants n=5 Participants	29 participants n=7 Participants	36 participants n=5 Participants	91 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Standard Therapy n=26 Participants Standard emergency department evaluation and treatment for headache	Medical Air at 15L/Min n=29 Participants Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache	Oxygen at 15 L / Min n=36 Participants Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
Time to Relief (Min)	92.2 Minutes Standard Deviation 84.4	83.9 Minutes Standard Deviation 45.3	35.4 Minutes Standard Deviation 29.8

SECONDARY outcome

Timeframe: Study duration

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.

Outcome measures

Measure	Standard Therapy n=26 Participants Standard emergency department evaluation and treatment for headache	Medical Air at 15L/Min n=29 Participants Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache	Oxygen at 15 L / Min n=36 Participants Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
Length of Stay in the Emergency Department(Min)	177.5 Minutes Standard Deviation 109	210.7 Minutes Standard Deviation 134.9	118.7 Minutes Standard Deviation 145.8

Adverse Events

Standard Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Air at 15L/Min

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxygen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Boris Veysman

UMDNJ

Phone: 732-235-8717

Email: veysmabo@umdnj.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place