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

NCT04381923 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-11-15
Completion
2022-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04381923 on ClinicalTrials.gov