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Completed

NCT Number: NCT06517745

Effect of Prone Positionning in Non Intubated Patients

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

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Key information

Conditions

SARS-CoV 2 Pneumonia Acute Respiratory Distress Syndrome Lung Diseases Prone Positioning Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mongi Slim hospital

Tunis, 2046, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone positioning

Procedure

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

Primary outcomes

  1. Intubation

    Time frame: at day 7

    invasive mechanical ventilation requirement

  2. Intubation

    Time frame: at day 14

    invasive mechanical ventilation requirement

Secondary outcomes

  1. ICU mortality

    Time frame: at Day 14

    observed mortality rate in the ICU

Sponsors and collaborators

Lead sponsor

Mongi Slim Hospital

Other

Registry information

Official study title

Prone Positionning in Non Intubated ICU Patients With SARS-COV2

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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