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.
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).
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.
Other Name: High Flow Nasal Cannula (HFNC)
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.
University of Pennsylvania
Philadelphia, Pennsylvania, United States