A Prospective Clinical Study to Explore Response to Prone Positioning in ARDS Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04692779|
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : February 18, 2021
|Condition or disease||Intervention/treatment|
|Covid19 ARDS||Other: Lung Ultrasound (LUS)|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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 :||January 31, 2021|
|Estimated Primary Completion Date :||October 30, 2021|
|Estimated Study Completion Date :||October 30, 2021|
|Intubated ARDS patients undergoing prone positioning||
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692779
|Contact: Tyler Weiss||312-947-3027||Tyler_Weiss@rush.edu|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Tyler Weiss 312-563-2050 Tyler_Weiss@rush.edu|
|Contact: Jie Li 312-942-4643 Jie_Li@rush.edu|
|Principal Investigator: Tyler Weiss, MS|
|Sub-Investigator: Jie Li, PhD|
|Sub-Investigator: Sara Mirza, MD|
|Sub-Investigator: Mark Yoder, MD|