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

Primary Purpose

ARDS, Covid19, Acute Hypoxemic Respiratory Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Prolonged Proned Positioning

Traditional Proning Arm

About this trial

This is an interventional treatment trial for ARDS

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolonged Proning Arm

Traditional Proning Arm

Arm Description

Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study

Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study

Outcomes

Primary Outcome Measures

Duration in Prone Position

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

Secondary Outcome Measures

Change in P:F Ratio

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

Change in Drive Pressure

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

Unplanned Extubations

Number of unplanned extubations

Pressure Ulcers

Number of patients with pressure ulcers

Line Displacement

Number of displaced central venous line or arterial line

Vent Free Days

Number of days free from mechanical ventilation

Mortality

Mortality at 30 days

Rescue Interventions

Patients in which new initiation of inhaled pulmonary vasodilators, ECMO

Tracheostomy

Number of patients who have placement of tracheostomy

ICU Free Days

Number of days not in ICU

S:F Ratio

Ratio of SpO2 to FiO2

Full Information

NCT ID

NCT04581811

First Posted

October 7, 2020

Last Updated

March 29, 2022

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT04581811

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 10, 2020 (Actual)

Primary Completion Date

March 20, 2021 (Actual)

Study Completion Date

March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ARDS, Covid19, Acute Hypoxemic Respiratory Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prolonged Proning Arm

Arm Type

Experimental

Arm Description

Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study

Arm Title

Traditional Proning Arm

Arm Type

Active Comparator

Arm Description

Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study

Intervention Type

Other

Intervention Name(s)

Prolonged Proned Positioning

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Traditional Proning Arm

Intervention Description

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 Measure Information:

Title

Duration in Prone Position

Description

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

Time Frame

96 hours

Secondary Outcome Measure Information:

Title

Change in P:F Ratio

Description

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

Time Frame