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

Not Applicable

Completed

• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Procedure: prolonged prone position ventilation

• Registration Number: NCT05109624
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-05
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group(B)	prolonged prone position ventilation	pronation cycles each last for 24 hours followed by 6 hours supine position

Primary Outcome Measures

Name	Time	Method
Incidence of complications	28 days	Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability
rate of successful weaning	28 days	how many patients successfully extubated, hospital survival, ICU stay

Secondary Outcome Measures

Name	Time	Method
Efficacy of oxygenation	28 days	mean value of change in PaO2/FiO2 ratio and static lung compliance before and after 3 successive proning cycles

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt