Helmet Non-Invasive Ventilation for COVID-19 Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helmet Non-Invasive Ventilation for COVID-19 Patients

Conditions
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COVID-19, Acute Hypoxemic Respiratory Failure

Intervention / Treatment
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* Device: Helmet non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helmet group<br>Patients will be allocated to helmet non-invasive ventilation | Device: Helmet non-invasive ventilation<br>* Patients will be allocated to helmet non-invasive ventilation<br>|
| No Intervention: Control group<br>Patients will be allocated to standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day all-cause mortality | all cause mortality | 28 days from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate within 28 days | endotracheal intubation | 28 days from randomization | 
| ICU mortality | ICU death | 180 days from randomization | 
| Hospital mortality (censored at day 180) | hospital death | 180 days from randomization | 
| Hospital length of stay | length of stay in the hospital | 180 days from randomization | 
| ICU free days at day 28 | days not in ICU | 28 days from randomization | 
| Invasive ventilation-free days at day 28 | days without ventilator support | 28 days from randomization | 
| Renal replacement therapy-free days at day 28 | days without renal replacement therapy received | 28 days from randomization | 
| Vasopressor-free days at day 28 | days without vasopressor support | 28 days from randomization | 
| Safety outcome: skin pressure ulcers | presence of pressure ulcers | 28 days from randomization | 
| Safety outcome: barotrauma | incidence of barotrauma | 28 days from randomization | 
| Serious adverse events (including cardiovascular events and device complications) | reporting of abovementioned adverse events | 28 days from randomization | 
| 180-day all-cause mortality | all cause mortality | 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. | 180 days from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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helmet nonivasive ventilation