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Completed

NCT Number: NCT05109624

Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2?

the aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2

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Key information

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University hospitals

Cairo, 11591, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - American Society of Anesthesiologists (ASA) physical status II- III.
  • Sex (male and females).
  • Age 18 -80 years.
  • Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of <150 mm Hg, with a fraction of inspired oxygen (FiO2) of ≥0.6, a positive end expiratory pressure (PEEP) of ≥5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight
  • mechanical ventilation for less than 36 hours

Exclusion criteria

  • - Contraindication for prone positioning
  • increased intracranial tension.
  • face trauma or surgery.
  • Recent Deep venous thrombosis
  • Unstable spine, femur, or pelvic fractures
  • Mean arterial pressure < 65 mm Hg
  • Pregnant women
  • Pneumothorax
  • Prone positioning before inclusion
  • Those returned to supine position before completing the session time

Treatment and study plan

prolonged prone position ventilation

Procedure

patients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation

Primary outcomes

  1. rate of successful weaning

    Time frame: 28 days

    how many patients successfully extubated, hospital survival, ICU stay

  2. Incidence of complications

    Time frame: 28 days

    Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability

Secondary outcomes

  1. Efficacy of oxygenation

    Time frame: 28 days

    mean value of change in PaO2/FiO2 ratio and static lung compliance before and after 3 successive proning cycles

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2? A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2021
Registry last updated
Feb 17, 2022

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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