COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID
- Hypoxemic Respiratory Failure
- Pneumonia, Viral
- Severe Acute Respiratory Syndrome Coronavirus 2
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This will be a randomized study with alternating treatment assignment in which all advanced respiratory units will be assigned to use one of two default interventions (helmet CPAP vs HFNO) as the first-line treatment for refractory hypoxemia (defined as an oxygen saturation (Sp02) of 92% or less on on ? 6 LPM (liters per minute) nasal cannula (NC) oxygen). The first-line treatment will be alternated in each unit at 14-day intervals. The initial assignment will be determined by a computer randomization scheme. Patients who are still on their assigned intervention during crossover will remain on that assigned intervention. A design with numerous short periods and frequent crossovers was selected to minimize the risk of changes over time in the patient population and usual care confounding trial results. A 14-day period is also felt to be the minimal time needed to ensure device availability and adherence.Masking: Single (Outcomes Assessor)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can cause acute arterial hypoxemia. Treatment with invasive ventilation improves oxygenation yet results in death in over 50% of cases. The high incidence of disease has also reduced resources needed to safely deliver invasive ventila...
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can cause acute arterial hypoxemia. Treatment with invasive ventilation improves oxygenation yet results in death in over 50% of cases. The high incidence of disease has also reduced resources needed to safely deliver invasive ventilation including mechanical ventilators and intravenous sedation. Non-invasive respiratory support has been shown to be efficacious in acute hypoxemic respiratory failure from other etiologies and has the potential to reduce rates of intubation and the time spent on mechanical ventilation in COVID-19. However, it is unknown which type of support is the most effective, limiting the ability to improve clinical outcomes and appropriately allocate resources. To help guide clinical practice and policy, it is critical to understand the comparative effectiveness of two forms of non-invasive respiratory support used worldwide, continuous positive airway pressure (CPAP) delivered via a helmet interface and high flow nasal oxygen (HFNO).
Tracking Information
- NCT #
- NCT04381923
- Collaborators
- Not Provided
- Investigators
- Not Provided
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