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

NCT04581811 | Completed Results DMC

• 1 other identifier: IRB-300005979
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS; Covid19; Acute Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Duration in Prone Position

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

  96 hours

Secondary Outcomes (11)

• Change in P:F Ratio

  End of supine session on day 4

• Change in Drive Pressure

  End of supine session on day 4

• Unplanned Extubations

  End of supine session on day 4

• Pressure Ulcers

  End of supine session on day 4

• Line Displacement

  End of supine session on day 4

Study Arms (2)

Prolonged Proning Arm

EXPERIMENTAL

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

Traditional Proning Arm

ACTIVE COMPARATOR

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

Interventions

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

Prolonged Proning Arm

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

Traditional Proning Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 34491885 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: David Page - PI
• Organization: UAB Hospital

dpage1@uabmc.edu

205-975-7387

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 9, 2020
• Study Start: November 10, 2020
• Primary Completion: March 20, 2021
• Study Completion: March 20, 2021
• Last Updated: March 31, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)