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

NCT04381923 | Withdrawn DMC FDA Device

• 1 other identifier: 843124
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• ICU and Hospital Length of Stay

  28 days

• Intubation

  28 days

• Renal Replacement Therapy (RRT)

  28 days

• Mortality

  28 days, 90 days

Study Arms (2)

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.

Device: Helmet Continuous Positive Airway Pressure (CPAP)

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

Device: High Flow Nasal Oxygen (HFNO)

Interventions

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.

Helmet Continuous Positive Airway Pressure (CPAP)

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.

Also known as: High Flow Nasal Cannula (HFNC)

High Flow Nasal Oxygen (HFNO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Pneumonia, Viral

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Critical Care

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 11, 2020
• Study Start: November 15, 2021
• Primary Completion: November 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

US (1)