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

July 28, 2021 updated by: Fekri Abroug, Hôpital Universitaire Fattouma Bourguiba

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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)

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • CHU F.Bourguiba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Covid-19 confirmed by rtPCR, suffering from acute hypoxemic failure requiring oxygenation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HFNC/prone
awake patients with COVID-19 and severe acute respiratory failure receiving HFNC in prone position
Procedure: prone position
patients are returned from prone to supine position while receiving oxygenation through HFNC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients without intubation
Time Frame: through study completion, an average of 28 days
successful oxygenation without intubation
through study completion, an average of 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Universitaire Fattouma Bourguiba

Investigators

  • Study Chair: Lamia Besbes, Prof, CPPRB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

March 3, 2021

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FattoumaBourguiba_HFNC_Prone

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoxemic Respiratory Failure

Clinical Trials on prone position

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe