NCT04381923

COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia

High Flow Nasal Oxygen Versus Continuous Positive Airway Pressure Helmet Evaluation: A Randomized Crossover Trial in COVID-19 Pneumonia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.

Detailed 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 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).

Conditions

• Severe Acute Respiratory Syndrome Coronavirus 2
• Hypoxemic Respiratory Failure
• Pneumonia, Viral
• COVID

Interventions

Type	Name	Description
DEVICE	Helmet Continuous Positive Airway Pressure (CPAP)	Helmet CPAP will be initiated at a pressure of 5 cmH20 and fraction of inspired oxygen (Fi02) of \< 60%. If oxygen saturation (Sp02) remains \< 92%, pressure will be increased to 10 cmH20. FiO2 will then be tapered to target a SpO2 ≥ 92%. Breaks with intervening HFNO use will be provided as needed for meals and during hours of sleep.
DEVICE	High Flow Nasal Oxygen (HFNO)	HFNO will be initiated at a flow rate of 40 LPM and a fraction of inspired oxygen (Fi02) of \< 60%. If oxygen saturation (SpO2) remains \< 92%, the flow rate will be increased to 60 LPM. FiO2 will then be adjusted to target a SpO2 ≥ 92%. Patients with discomfort due to HFNO may have their flow rate decreased until the discomfort resolves.

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-11-15
• Completion: 2022-12-15
• First posted: 2020-05-11
• Last updated: 2022-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study