A Prospective Clinical Study to Explore Response to Prone Positioning in ARDS Patients

October 2, 2025 updated by: Tyler Weiss, Rush University Medical Center

A Prospective Clinical Study to Explore the Mechanism of Patients' Response to Prone Positioning in ARDS Patients, Including COVID-19

The proposed study will be conducted to investigate the mechanism of patients' responses to prone positioning with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS utilizing lung ultrasound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study of adult patients with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS who are intubated, in the prone position and receiving mechanical ventilation in the intensive care units at Rush University Medical Center. In this study design, we will prospectively enroll subjects, who fulfill eligibility criteria, to investigate the mechanism of their responses to the first three prone positioning sessions, utilizing lung ultrasound (LUS). Inclusion criteria include: adult subjects 18 years and older with a diagnosis of ARDS, endotracheally intubated and receiving assisted mechanical ventilation, meet criteria for prone positioning (ratio of arterial oxygen tension to the fraction of inspired oxygen (PaO2/FiO2) of ≤ 150 mm Hg with ventilator parameters of positive end-expiratory pressure (PEEP) ≥ 10 cm H2O and FiO2 of .60, and order for prone positioning. Patients will be excluded from the study if they meet the following criteria: pregnant, tracheostomy, receiving extracorporeal membrane oxygenation (ECMO), palliative care, received prone positioning more than once during intubation in an outside hospital, or receive invasive ventilation in an outside hospital for more than 72 hours. Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Intubated adults (18 years or older) with a diagnosis of ARDS receiving mechanical ventilation and meet criteria for prone positioning.

Description

Inclusion Criteria:

  1. Adult subjects 18 years and older, diagnosis of ARDS
  2. endotracheally intubated and receiving assisted mechanical ventilation
  3. meet criteria for prone positioning: PaO2/FIO2 (P/F ratio) of ≤ 150 mm Hg with ventilator parameters of PEEP ≥ 10 cm H2O and FiO2 of .60
  4. receive an order for prone positioning.

Exclusion Criteria:

  1. Pregnant
  2. Tracheostomy
  3. Receiving ECMO
  4. Palliative care
  5. Receive prone positioning more than once during intubation in an outside hospital
  6. Receive invasive ventilation in an outside hospital for more than 72 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intubated ARDS patients undergoing prone positioning
All intubated ARDS patients undergoing prone positioning will be assessed with LUS before and after prone positioning and before and after placing back in the supine position.
Other: Lung Ultrasound (LUS)
Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation and Lung Ultrasound Score (LUS)
Time Frame: 10 months
Patients' responses of oxygenation and lung ultrasound score (0 - 36 where 0 = normal lung aeration and 36 = most severe lung consolidation) to prone positioning in the first three prone positioning sessions for ARDS patients.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 ARDS vs non-COVID-19 ARDS
Time Frame: 10 months
observed lung ultrasound score (0 - 36 where 0 = normal lung aeration and 36 = most severe lung consolidation) differences between patients who respond to prone positioning and those who do not respond among patients with COVID-19 ARDS and non-COVID-19 ARDS.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Tyler Weiss, MS, Rush University Medical Center
  • Study Chair: Jie Li, PhD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

December 6, 2024

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProneARDS

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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