Status:
WITHDRAWN
COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia
Lead Sponsor:
University of Pennsylvania
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
Hypoxemic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 CP...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04381923
Start Date
November 15 2021
End Date
December 15 2022
Last Update
April 5 2022
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104