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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT02236559
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (\> 18 yrs of age)
* Presentation with acute respiratory failure according to the following criteria:
* If any of these are present: Respiratory Rate \>22 or labored; Suspected Acute Respiratory Acidosis, as defined as pH \<7.32 on initial blood gas(either arterial or venous); Hypoxemia, as defined as Pulse Ox \<92%;
* Clinical decision to escalate therapy to non-invasive ventilatory support, or to maintain non-invasive ventilatory support if delivered to the ED on such.
Exclusion Criteria:
* Suspected drug overdose
* Cardiovascular instability as demonstrated by hypotension relative to initial clinical presentation that requires immediate intervention
* End stage cancer
* Life expectancy \< 6 months
* Respiratory arrest or significant respiratory depression on presentation
* Glasgow Coma Scale score \< 9
* Cardiac arrest on initial presentation
* Need for emergent intubation
* Known or suspected cerebrovascular accident
* Known or suspected ST segment elevation myocardial infarction
* Patients with increased risk of pulmonary aspiration
* Agitation or uncooperativeness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02236559
Study Brief:
Protocol Section:
NCT02236559