NCT06517745

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

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

January 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

July 22, 2024

Last Update Submit

July 22, 2024

Conditions

SARS-CoV 2 PneumoniaAcute Respiratory Distress SyndromeProne Positioning

Outcome Measures

Primary Outcomes (2)

  • Intubation

    invasive mechanical ventilation requirement

    at day 7

  • Intubation

    invasive mechanical ventilation requirement

    at day 14

Secondary Outcomes (1)

  • ICU mortality

    at Day 14

Study Arms (2)

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

Prone positioningPROCEDURE

Prone positioning sessions: at least one session per day proning duration: 2 hours at least per session

Prone position group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim hospital

Tunis, 2046, Tunisia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor head of Anesthesiology and ICU department

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 24, 2024

Study Start

January 1, 2021

Primary Completion

September 30, 2021

Study Completion

October 30, 2021

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations

TU(1)