Helmet Non-Invasive Ventilation for COVID-19 Patients
- Conditions
- COVID-19Acute Hypoxemic Respiratory Failure
- Interventions
- Device: Helmet non-invasive ventilation
- Registration Number
- NCT04477668
- 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 hypoxemic respiratory failure
- 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 in multiple centers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 322
- Suspected or confirmed COVID-19
- Aged β₯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.)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Helmet group Helmet non-invasive ventilation Patients will be allocated to helmet non-invasive ventilation
- Primary Outcome Measures
Name Time Method 28-day all-cause mortality 28 days from randomization all cause mortality
- Secondary Outcome Measures
Name Time Method ICU mortality 180 days from randomization ICU death
ICU free days at day 28 28 days from randomization days not in ICU
Vasopressor-free days at day 28 28 days from randomization days without vasopressor support
Serious adverse events (including cardiovascular events and device complications) 28 days from randomization reporting of abovementioned adverse events
Renal replacement therapy-free days at day 28 28 days from randomization days without renal replacement therapy received
Safety outcome: barotrauma 28 days from randomization incidence of barotrauma
Hospital length of stay 180 days from randomization length of stay in the hospital
Intubation rate within 28 days 28 days from randomization endotracheal intubation
Hospital mortality (censored at day 180) 180 days from randomization hospital death
Invasive ventilation-free days at day 28 28 days from randomization days without ventilator support
Safety outcome: skin pressure ulcers 28 days from randomization presence of pressure ulcers
180-day all-cause mortality 180 days from randomization all cause mortality
Follow-up study: 180-day 5-level EQ-5D version 180 days from randomization The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Trial Locations
- Locations (1)
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
πΈπ¦Riyadh, Saudi Arabia