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Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581811
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
David Page, University of Alabama at Birmingham

Brief Summary:
Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.

Condition or disease Intervention/treatment Phase
ARDS Covid19 Acute Hypoxemic Respiratory Failure Other: Prolonged Proned Positioning Other: Traditional Proning Arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: Prolonged Proning Arm
Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study
Other: Prolonged Proned Positioning
Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period

Active Comparator: Traditional Proning Arm
Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study
Other: Traditional Proning Arm
Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period




Primary Outcome Measures :
  1. Duration in prone position [ Time Frame: 96 hours ]
    Time spent in the prone position


Secondary Outcome Measures :
  1. Change in P:F ratio [ Time Frame: 96 hours ]
    Change in P:F ratio from immediately prior to initiation of prone positioning to end of study period

  2. Change in Drive Pressure [ Time Frame: 96 hours ]
    Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period

  3. Unplanned extubations [ Time Frame: 96 hours ]
    Number of unplanned extubations

  4. Pressure ulcers [ Time Frame: 96 hours ]
    Number of pressure ulcers

  5. Line displacement [ Time Frame: 96 hours ]
    Number of displaced central venous line or arterial line

  6. Duration of mechanical ventilation [ Time Frame: 30 days ]
    Number of days on mechanical ventilation

  7. Mortality [ Time Frame: 30 days ]
    Mortality

  8. Rescue Interventions [ Time Frame: 96 hours ]
    New initiation of inhaled pulmonary vasodilators, ECMO



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Positive COVID test Endotracheal Intubation P:F <150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU.

Exclusion Criteria:

Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for >48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581811


Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: David B Page, M.D.    205-975-7387    dpage1@uabmc.edu   
Sub-Investigator: Derek Russell, M.D.         
Sub-Investigator: Mark Dransfield, M.D.         
Sponsors and Collaborators
University of Alabama at Birmingham
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Responsible Party: David Page, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04581811    
Other Study ID Numbers: IRB-300005979
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury