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CompletedNCT06517745Updated Jul 24, 2024

Effect of Prone Positionning in Non Intubated Patients

An observational study in SARS-CoV 2 Pneumonia, Acute Respiratory Distress Syndrome and Prone Positioning, sponsored by Mongi Slim Hospital. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Mongi Slim Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
114
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • SARS-CoV 2 Pneumonia
  • Acute Respiratory Distress Syndrome
  • Prone Positioning
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 114 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Mongi Slim Hospital is the lead sponsor of 37 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
114 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureProne positioning

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

06

What researchers measure

Primary outcomes

  1. Intubation

    invasive mechanical ventilation requirement

    Time frame: at day 7

  2. Intubation

    invasive mechanical ventilation requirement

    Time frame: at day 14

Secondary outcomes

  1. ICU mortality

    observed mortality rate in the ICU

    Time frame: at Day 14

07

Study locations

1 site
  • Mongi Slim hospital
    Tunis, 2046, Tunisia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06517745
Lead sponsor
Mongi Slim Hospital
Responsible party
Mhamed Sami Mebazaa (Professor head of Anesthesiology and ICU department, Mongi Slim Hospital) — Principal investigator
First posted
Jul 24, 2024
Start date
Jan 1, 2021
Primary completion
Sep 30, 2021
Completion
Oct 30, 2021
Last update
Jul 24, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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