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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT04477668
Eligibility Criteria:
Inclusion Criteria:
* Suspected or confirmed COVID-19
* Aged ≥14 years old at the participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years)
* Acute hypoxemic respiratory failure based on PaO2/FiO2 ratio \<200 despite supplemental oxygen with a partial or non-rebreathing mask at a flow rate \>10 L/min or above
* Intact airway protective gag reflex
* Able to follow instructions (e.g. squeeze hand on command, eye contact with care provider, stick out tongue on command, etc.)
Exclusion Criteria:
* Prior intubation during this hospital admission
* Cardiopulmonary arrest
* Glasgow coma scale \<12
* Tracheostomy
* Upper airway obstruction
* Active epistaxis
* Requirement for more than one vasopressor to maintain mean arterial pressure \> 65 mm Hg
* Pregnancy
* Imminent intubation
* Patients with do not intubate orders or equivalent
* Enrolled in another trial for which co-enrolment is not approved including trials on mechanical ventilation
* Patients already treated with helmet
* Patients with chronic carbon dioxide retention (PaCO2 \>45)
* Previous enrolment in this trial
* The primary cause of respiratory failure is not heart failure as judged by the treating team
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT04477668
Study Brief:
Protocol Section:
NCT04477668