NCT04982341

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 19, 2021

Last Update Submit

July 28, 2021

Conditions

Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Number of patients without intubation

    successful oxygenation without intubation

    through study completion, an average of 28 days

Study Arms (1)

HFNC/prone

awake patients with COVID-19 and severe acute respiratory failure receiving HFNC in prone position

Procedure: prone position

Interventions

prone positionPROCEDURE

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

HFNC/prone

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • aged ≥18 years, admitted to the medical ICU for confirmed Covid-19 and acute hypoxemic respiratory failure

You may not qualify if:

  • patients already intubated at admission or those requiring immediate intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU F.Bourguiba

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lamia Besbes, Prof

    CPPRB

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Head of the ICU

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 29, 2021

Study Start

September 2, 2020

Primary Completion

March 3, 2021

Study Completion

March 3, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)