Effect of Prone Positionning in Non Intubated Patients | NCT06517745

Studies
Effect of Prone Positionning in Non Intubated Patients

NCT06517745

Sponsor

Mongi Slim Hospital

Status

Completed

Last Update Posted

Jul 24, 2024Actual

Enrollment

114Actual

Phase

Not provided

Conditions

SARS-CoV 2 Pneumonia
Acute Respiratory Distress Syndrome
Prone Positioning

Interventions

Prone positioning

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 2024

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

Jan 1, 2021Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Oct 30, 2021Actual

First Submitted Date

Jul 22, 2024

First Submission Date that Met QC Criteria

Jul 22, 2024

First Posted Date

Jul 24, 2024Actual

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 22, 2024

Last Update Posted Date

Jul 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mhamed Sami Mebazaa, Professor head of Anesthesiology and ICU department, Mongi Slim HospitalPrincipal Investigator

Lead Sponsor

Mongi Slim HospitalOTHER

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

Retrospective single center study on the effect of awake prone positioning in ICU patients with severe hypoxemia related to SARS-COV2

Detailed Description

Retrospective, observational study on the effects of awake prone positioning on oxygenation, invasive mechanical ventilation requirement and mortality in non intubation patients with severe hypoxemia related to SARS-COV2 and regardeless of the oxygen supplementation method.

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

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prone position group		Prone positioning sessions: at least 1 session per day session duration: at least 2 hours	Procedure: Prone positioning
Control group		no prone positioning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prone positioning	Procedure	Prone positioning sessions: at least one session per day proning duration: 2 hours at least per session	Prone position group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intubation	invasive mechanical ventilation requirement	at day 7
Intubation	invasive mechanical ventilation requirement	at day 14

Secondary Outcomes

Measure	Description	Time Frame
ICU mortality	observed mortality rate in the ICU	at Day 14

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult (> 18 years) patients, non intubated, with acute respiratory failure due to COVID-19 pulmonary infection

Exclusion Criteria:

patients: hemodynamic instability and high doses of vasopressors
patients with contraindications of prone positioning: pregnancy, recent abdominal surgery
patients with pulmonay embolism
patients requiring invasive mechanical ventilation for extra respiratory reasons: neurological failure, urgent surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adult (> 18 years) patients admitted in the ICU:

with acute respiratory failure due to COVID-19 pulmonary infection
non intubated
regardeless of the exygenation method: HFONC, face mask, non invasive ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mongi Slim hospital		Tunis		2046	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

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