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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: prolonged prone position ventilation

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain shams university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: group(A) control group; pronation cycles each last for 16 hours every 24 hours
Active Comparator: group(B); pronation cycles each last for 24 hours followed by 6 hours supine position	Procedure: prolonged prone position ventilation; patients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: FMASU R 160 / 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No