HFNC and Prone Positioning in Awake Patients With Severe... | NCT04982341

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

NCT04982341

Sponsor

Hôpital Universitaire Fattouma Bourguiba

Status

Completed

Last Update Posted

Jul 29, 2021Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Hypoxemic Respiratory Failure

Interventions

prone position

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2020Actual

Primary Completion Date

Mar 3, 2021Actual

Completion Date

Mar 3, 2021Actual

First Submitted Date

Jul 19, 2021

First Submission Date that Met QC Criteria

Jul 28, 2021

First Posted Date

Jul 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2021

Last Update Posted Date

Jul 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fekri Abroug, Professor Head of the ICU, Hôpital Universitaire Fattouma BourguibaPrincipal Investigator

Lead Sponsor

Hôpital Universitaire Fattouma BourguibaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HFNC/prone		awake patients with COVID-19 and severe acute respiratory failure receiving HFNC in prone position	Procedure: prone position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prone position	Procedure	patients are returned from prone to supine position while receiving oxygenation through HFNC	HFNC/prone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Lamia Besbes, Prof	CPPRB	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
CHU F.Bourguiba		Monastir		5000	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016684	Prone Position

Ancestor Terms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided