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Completed

NCT Number: NCT04581811

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

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.

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Key information

Conditions

ARDS Acute Hypoxemic Respiratory Failure COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Prolonged Proned Positioning

Other

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

Traditional Proning Arm

Other

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 outcomes

  1. Duration in Prone Position

    Time frame: 96 hours

    Time spent in the prone position of hours eligible for prone positioning

Secondary outcomes

  1. Change in P:F Ratio

    Time frame: End of supine session on day 4

    Change in PaO2 on ABG to FiO2 ratio from immediately prior to initiation of prone positioning to end of study period

  2. Change in Drive Pressure

    Time frame: End of supine session on day 4

    Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period

  3. Unplanned Extubations

    Time frame: End of supine session on day 4

    Number of unplanned extubations

  4. Pressure Ulcers

    Time frame: End of supine session on day 4

    Number of patients with pressure ulcers

  5. Line Displacement

    Time frame: End of supine session on day 4

    Number of displaced central venous line or arterial line

  6. Vent Free Days

    Time frame: 30 days

    Number of days free from mechanical ventilation

  7. Mortality

    Time frame: 30 days

    Mortality at 30 days

  8. Rescue Interventions

    Time frame: 96 hours

    Patients in which new initiation of inhaled pulmonary vasodilators, ECMO

  9. Tracheostomy

    Time frame: 30 days

    Number of patients who have placement of tracheostomy

  10. ICU Free Days

    Time frame: 30 days

    Number of days not in ICU

  11. S:F Ratio

    Time frame: 96 hours

    Ratio of SpO2 to FiO2

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2020
Registry last updated
Mar 31, 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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