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

Not Applicable

Withdrawn

• Conditions: COVID; Severe Acute Respiratory Syndrome Coronavirus 2; Hypoxemic Respiratory Failure; Pneumonia, Viral
• Interventions: Device: High Flow Nasal Oxygen (HFNO); Device: Helmet Continuous Positive Airway Pressure (CPAP)

• Registration Number: NCT04381923
• Lead Sponsor: University of Pennsylvania

Brief 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).

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-11
• Study Start: 2021-11-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-04-05
• Primary Completion: 2022-11-15
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Flow Nasal Oxygen (HFNO)	High Flow Nasal Oxygen (HFNO)	When a patient has an Sp02 \< 92% on ≥ 6 LPM NC , HFNO (≥ 40 LPM) will be applied unless a specific contraindication is present
Helmet Continuous Positive Airway Pressure (CPAP)	Helmet Continuous Positive Airway Pressure (CPAP)	When a patient has an Sp02 \< 92% on ≥ 6 LPM NC, helmet CPAP will be applied unless a specific contraindication is present.

Primary Outcome Measures

Name	Time	Method
Ventilator-Free Days (VFD)	28 days	VFD is the number of days alive and free of mechanical ventilation in the first 28 days after study enrollment. Death before 28 days will be assigned a VFD equal to 0 to penalize non-survival. In cases of repeated intubation and extubation, periods free from invasive ventilation and lasting at least 24 consecutive hours will be calculated and summed. Timing of intubation and extubation will be captured in hours, and the number of hours a patient received invasive ventilation will be used to calculate duration of ventilation.

Secondary Outcome Measures

Name	Time	Method
Renal Replacement Therapy (RRT)	28 days	Incidence of RRT after the time of enrollment
Mortality	28 days, 90 days	Death from any cause during after the time of enrollment
ICU and Hospital Length of Stay	28 days	Days spent in the ICU and hospital after time of enrollment
Intubation	28 days	Incidence and time to intubation in days after the time of enrollment

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States