Back to resultsCOVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia (COVIDNOCHE)
Primary Purpose
Severe Acute Respiratory Syndrome Coronavirus 2, Hypoxemic Respiratory Failure, Pneumonia, Viral
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helmet Continuous Positive Airway Pressure (CPAP)
High Flow Nasal Oxygen (HFNO)
Sponsored by
About this trial
This is an interventional supportive care trial for Severe Acute Respiratory Syndrome Coronavirus 2
Eligibility Criteria
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.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Helmet Continuous Positive Airway Pressure (CPAP)
High Flow Nasal Oxygen (HFNO)
Arm Description
When a patient has an Sp02 < 92% on ≥ 6 LPM NC, helmet CPAP will be applied unless a specific contraindication is present.
When a patient has an Sp02 < 92% on ≥ 6 LPM NC , HFNO (≥ 40 LPM) will be applied unless a specific contraindication is present
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
ICU and Hospital Length of Stay
Days spent in the ICU and hospital after time of enrollment
Intubation
Incidence and time to intubation in days after the time of enrollment
Renal Replacement Therapy (RRT)
Incidence of RRT after the time of enrollment
Mortality
Death from any cause during after the time of enrollment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04381923
Brief Title
COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia
Acronym
COVIDNOCHE
Official Title
High Flow Nasal Oxygen Versus Continuous Positive Airway Pressure Helmet Evaluation: A Randomized Crossover Trial in COVID-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain IRB approval
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Respiratory Syndrome Coronavirus 2, Hypoxemic Respiratory Failure, Pneumonia, Viral, COVID
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Helmet Continuous Positive Airway Pressure (CPAP)
Arm Type
Active Comparator
Arm Description
When a patient has an Sp02 < 92% on ≥ 6 LPM NC, helmet CPAP will be applied unless a specific contraindication is present.
Arm Title
High Flow Nasal Oxygen (HFNO)
Arm Type
Active Comparator
Arm Description
When a patient has an Sp02 < 92% on ≥ 6 LPM NC , HFNO (≥ 40 LPM) will be applied unless a specific contraindication is present
Intervention Type
Device
Intervention Name(s)
Helmet Continuous Positive Airway Pressure (CPAP)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Oxygen (HFNO)
Other Intervention Name(s)
High Flow Nasal Cannula (HFNC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilator-Free Days (VFD)
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
ICU and Hospital Length of Stay
Description
Days spent in the ICU and hospital after time of enrollment
Time Frame
28 days
Title
Intubation
Description
Incidence and time to intubation in days after the time of enrollment
Time Frame
28 days
Title
Renal Replacement Therapy (RRT)
Description
Incidence of RRT after the time of enrollment
Time Frame
28 days
Title
Mortality
Description
Death from any cause during after the time of enrollment
Time Frame
28 days, 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia
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