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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; ARDS; Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Other: Prolonged Proned Positioning; Other: Traditional Proning Arm

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

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration in Prone Position	Time spent in the prone position of hours eligible for prone positioning	96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	End of supine session on day 4
Change in Drive Pressure	Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period	End of supine session on day 4
Unplanned Extubations	Number of unplanned extubations	End of supine session on day 4
Pressure Ulcers	Number of patients with pressure ulcers	End of supine session on day 4
Line Displacement	Number of displaced central venous line or arterial line	End of supine session on day 4
Vent Free Days	Number of days free from mechanical ventilation	30 days
Mortality	Mortality at 30 days	30 days
Rescue Interventions	Patients in which new initiation of inhaled pulmonary vasodilators, ECMO	96 hours
Tracheostomy	Number of patients who have placement of tracheostomy	30 days
ICU Free Days	Number of days not in ICU	30 days
S:F Ratio	Ratio of SpO2 to FiO2	96 hours

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Publications and helpful links

General Publications

• Page DB, Vijaykumar K, Russell DW, Gandotra S, Chiles JW, Whitson MR, Dransfield MT. Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome: A Randomized Pilot Clinical Trial. Ann Am Thorac Soc. 2022 Apr;19(4):685-687. doi: 10.1513/AnnalsATS.202104-498RL. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): March 20, 2021
• Study Completion (Actual): March 20, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: IRB-300005979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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