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

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ClinicalTrials.gov Identifier: NCT04692779
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Tyler Weiss, Rush University Medical Center

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
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.

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Study Type : Observational
Estimated 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 : January 31, 2021
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Tyler Weiss 312-947-3027 Tyler_Weiss@rush.edu

Locations
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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         
Sponsors and Collaborators
Rush University Medical Center
Publications of Results:

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Responsible Party: Tyler Weiss, Clinical Education Coordinator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04692779    
Other Study ID Numbers: ProneARDS
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tyler Weiss, Rush University Medical Center:
Prone positioning
Lung ultrasound