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

University of Pennsylvania

Status: Withdrawn

Conditions: COVID; Hypoxemic Respiratory Failure; Pneumonia, Viral; Severe Acute Respiratory Syndrome Coronavirus 2

Treatments: Device: Helmet Continuous Positive Airway Pressure (CPAP); Device: High Flow Nasal Oxygen (HFNO)

Study type: Interventional

Funder types: Other

Identifiers

NCT04381923

843124

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with confirmed COVID-19 with an Sp02 < 92% on ≥ 6 liters NC admitted to a Penn Medicine advanced respiratory unit. An advanced respiratory unit is a unit capable of non-invasive respiratory support such as an ICU or intermediate care unit.

Exclusion criteria

Patients will be excluded if they meet ≥ 1 of the following criteria based on current Penn Medicine respiratory guidelines and prior trials of non-invasive respiratory support:

• Respiratory failure related to other etiology (e.g. exacerbation of chronic obstructive pulmonary disease, acute pulmonary edema)
• Baseline oxygen requirement
• Diagnosis of acute or chronic hypoventilation
• Tracheostomy
• Claustrophobia
• Prior intubation during hospitalization
• Urgent need for endotracheal intubation
• Other contraindications to non-invasive respiratory support (glasgow coma scale lower than 8, absence of airway protective gag reflex, elevated intracranial pressure, upper airway obstruction)
• Patient dose not wave to receive the assigned intervention.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Helmet Continuous Positive Airway Pressure (CPAP)

Active Comparator group

Description:

When a patient has an Sp02 \< 92% on ≥ 6 LPM NC, helmet CPAP will be applied unless a specific contraindication is present.

Treatment:

Device: Helmet Continuous Positive Airway Pressure (CPAP)

High Flow Nasal Oxygen (HFNO)

Active Comparator group

Description:

When a patient has an Sp02 \< 92% on ≥ 6 LPM NC , HFNO (≥ 40 LPM) will be applied unless a specific contraindication is present

Treatment:

Device: High Flow Nasal Oxygen (HFNO)