Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT00856232
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 \_\_\_\_\_
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00856232
Study Brief:
Protocol Section:
NCT00856232