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

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04692779
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; ARDS	Other: Lung Ultrasound (LUS)

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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Clinical Study to Explore the Mechanism of Patients' Response to Prone Positioning in ARDS Patients, Including COVID-19
• Actual Study Start Date: Jan 31, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. Oxygenation and Lung Ultrasound Score (LUS) [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.

Secondary Outcome Measures

1. COVID-19 ARDS vs non-COVID-19 ARDS [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Rush University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tyler Weiss, Clinical Education Coordinator, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT04692779
• Other Study ID Numbers: ProneARDS
• First Posted: Jan 5, 2021
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tyler Weiss, Clinical Education Coordinator, Rush University Medical Center: Prone positioning; Lung ultrasound
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Aug 18, 2022