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

Primary Purpose

COVID-19 Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
prolonged prone position ventilation
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

group(A) control group

group(B)

Arm Description

pronation cycles each last for 16 hours every 24 hours

pronation cycles each last for 24 hours followed by 6 hours supine position

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2021
Last Updated
February 16, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05109624
Brief Title
Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2?
Official Title
Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2? A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group(A) control group
Arm Type
No Intervention
Arm Description
pronation cycles each last for 16 hours every 24 hours
Arm Title
group(B)
Arm Type
Active Comparator
Arm Description
pronation cycles each last for 24 hours followed by 6 hours supine position
Intervention Type
Procedure
Intervention Name(s)
prolonged prone position ventilation
Intervention Description
patients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation
Primary Outcome Measure Information:
Title
rate of successful weaning
Description
how many patients successfully extubated, hospital survival, ICU stay
Time Frame
28 days
Title
Incidence of complications
Description
Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Efficacy of oxygenation
Description
mean value of change in PaO2/FiO2 ratio and static lung compliance before and after 3 successive proning cycles
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

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

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