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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet Continuous Positive Airway Pressure (CPAP) | Active Comparator | When a patient has an Sp02 < 92% on ≥ 6 LPM NC, helmet CPAP will be applied unless a specific contraindication is present. |
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| High Flow Nasal Oxygen (HFNO) | Active Comparator | When a patient has an Sp02 < 92% on ≥ 6 LPM NC , HFNO (≥ 40 LPM) will be applied unless a specific contraindication is present |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helmet Continuous Positive Airway Pressure (CPAP) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-Free Days (VFD) | 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU and Hospital Length of Stay | Days spent in the ICU and hospital after time of enrollment | 28 days |
| Intubation | Incidence and time to intubation in days after the time of enrollment |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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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.
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| High Flow Nasal Oxygen (HFNO) | Device | 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. |
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| 28 days |
| Renal Replacement Therapy (RRT) | Incidence of RRT after the time of enrollment | 28 days |
| Mortality | Death from any cause during after the time of enrollment | 28 days, 90 days |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D008171 | Lung Diseases |