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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
322
Patients will be allocated to helmet non-invasive ventilation
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Saudi Arabia
28-day all-cause mortality
all cause mortality
Time frame: 28 days from randomization
Intubation rate within 28 days
endotracheal intubation
Time frame: 28 days from randomization
ICU mortality
ICU death
Time frame: 180 days from randomization
Hospital mortality (censored at day 180)
hospital death
Time frame: 180 days from randomization
Hospital length of stay
length of stay in the hospital
Time frame: 180 days from randomization
ICU free days at day 28
days not in ICU
Time frame: 28 days from randomization
Invasive ventilation-free days at day 28
days without ventilator support
Time frame: 28 days from randomization
Renal replacement therapy-free days at day 28
days without renal replacement therapy received
Time frame: 28 days from randomization
Vasopressor-free days at day 28
days without vasopressor support
Time frame: 28 days from randomization
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Safety outcome: skin pressure ulcers
presence of pressure ulcers
Time frame: 28 days from randomization
Safety outcome: barotrauma
incidence of barotrauma
Time frame: 28 days from randomization
Serious adverse events (including cardiovascular events and device complications)
reporting of abovementioned adverse events
Time frame: 28 days from randomization
180-day all-cause mortality
all cause mortality
Time frame: 180 days from randomization
Follow-up study: 180-day 5-level EQ-5D version
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.
Time frame: 180 days from randomization