Status:
COMPLETED
Helmet Non-Invasive Ventilation for COVID-19 Patients
Lead Sponsor:
King Abdullah International Medical Research Center
Collaborating Sponsors:
King Abdulaziz Medical City, Riyadh, Saudi Arabia
King Fahd Hospital of the University, Al Khobar, Saudi Arabia
Conditions:
COVID-19
Acute Hypoxemic Respiratory Failure
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypo...
Detailed Description
This will be a pragmatic parallel randomized control trial that will compare helmet nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The trial will be implemented i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT04477668
Start Date
February 8 2021
End Date
June 30 2022
Last Update
September 9 2022
Active Locations (1)
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1
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Saudi Arabia, 11426