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

Sponsor

Hôpital Universitaire Fattouma Bourguiba (Other)

Overall Status

Completed

CT.gov ID

NCT04982341

Collaborator

(none)

120

Enrollment

Location

Actual Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypoxemic Respiratory Failure	Procedure: prone position

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 Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 2, 2020

Actual Primary Completion Date :

Mar 3, 2021

Actual Study Completion Date :

Mar 3, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Number of patients without intubation [through study completion, an average of 28 days]
successful oxygenation without intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU F.Bourguiba	Monastir		Tunisia	5000

Sponsors and Collaborators

Hôpital Universitaire Fattouma Bourguiba

Investigators

Study Chair: Lamia Besbes, Prof, CPPRB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fekri Abroug, Professor Head of the ICU, Hôpital Universitaire Fattouma Bourguiba

ClinicalTrials.gov Identifier:

NCT04982341

Other Study ID Numbers:

FattoumaBourguiba_HFNC_Prone

First Posted:

Jul 29, 2021

Last Update Posted:

Jul 29, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Jul 29, 2021