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NCT04982341 Clinical Trial

HFNC and Prone Positioning in Awake Patients With Severe COVID-19

Hypoxemic Respiratory Failure Clinical Trial

Official title:
Effectiveness of High-flow Nasal Cannula and Prone Positioning in Awake Patients With COVID-19 and Severe Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04982341
Other study ID # FattoumaBourguiba_HFNC_Prone
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2, 2020
Est. completion date March 3, 2021

Study information
Verified date July 2021
Source Hôpital Universitaire Fattouma Bourguiba
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF.

Description:

The investigators evaluate the effects of High-flow nasal cannula (HFNC) in association with prone in patients with Covid-19 severe ARF. All patients with ARF related to Covid-19 and admitted to the ICU are turned in prone position whenever tolerated, while receiving oxygenation with HFNC. Outcomes of interest are the rate of success or failure (defined as the need for intubation and mechanical ventilation)

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 3, 2021
Est. primary completion date March 3, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - aged =18 years, admitted to the medical ICU for confirmed Covid-19 and acute hypoxemic respiratory failure Exclusion Criteria: - patients already intubated at admission or those requiring immediate intubation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• prone position
patients are returned from prone to supine position while receiving oxygenation through HFNC

Locations
Country Name City State
Tunisia CHU F.Bourguiba Monastir

Sponsors (1)
Lead Sponsor Collaborator
Hôpital Universitaire Fattouma Bourguiba

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients without intubation successful oxygenation without intubation through study completion, an average of 28 days
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