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 hypoxemic respiratory failure
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 in multiple centers.
Device: Helmet non-invasive ventilation
Patients will be allocated to helmet non-invasive ventilation
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
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Saudi Arabia
Yaseen Arabi, MD, Principal Investigator
King Abdulaziz Medical City - Riyadh