Effect of Prone Positionning in Non Intubated Patients

Completed

• Conditions: Acute Respiratory Distress Syndrome; SARS-CoV 2 Pneumonia; Prone Positioning
• Interventions: Procedure: Prone positioning

• Registration Number: NCT06517745
• Lead Sponsor: Mongi Slim Hospital

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prone position group	Prone positioning	Prone positioning sessions: at least 1 session per day session duration: at least 2 hours

Primary Outcome Measures

Name	Time	Method
Intubation	at day 14	invasive mechanical ventilation requirement

Secondary Outcome Measures

Name	Time	Method
ICU mortality	at Day 14	observed mortality rate in the ICU

Trial Locations

Locations (1)

Mongi Slim hospital; 🇹🇳 Tunis, Tunisia