Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning

Sponsor
Rush University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04855162
Collaborator
Hospital Civil de Guadalajara (Other)
74
2
3.1
37
12

Study Details

Study Description

Brief Summary

The primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Lung ultrasound (LUS) has recently gained popularity among the imaging methods to perform bedside assessment of critically ill patients to guide clinical management. LUS is a non-invasive and easy-to-perform procedure that provides precise data on lung aeration, lung recruitment, lung morphology, and lung perfusion. Studies have shown that LUS is a useful tool in monitoring lung reaeration in intubated patients diagnosed with traditional ARDS undergoing prone positioning; however there are mixed findings in terms of the use of LUS in predicting potential prone positioning response. A recent study found that the non-intubated COVID-19 patients who responded to prone positioning had more pronounced disturbances of aeration in posterior regions, however, they only investigated patients' response to the first prone positioning and the information for the patients' outcome is lacking. In our previous study with intubated COVID-19 patients, we found that patients' response to the subsequent prone positioning had higher predictive value than the response to the first prone positioning. Therefore, the primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    74 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning
    Actual Study Start Date :
    Jul 21, 2021
    Actual Primary Completion Date :
    Oct 7, 2021
    Actual Study Completion Date :
    Oct 23, 2021

    Outcome Measures

    Primary Outcome Measures

    1. SpO2/FiO2 pre prone in day 1 [pre prone in day 1]

      Patients' response of oxygenation using SpO2/FiO2

    2. SpO2/FiO2 post prone in day 1 [post prone in day 1]

      Patients' response of oxygenation using SpO2/FiO2

    3. SpO2/FiO2 pre prone in day 2 [Pre prone in day 2]

      Patients' response of oxygenation using SpO2/FiO2

    4. SpO2/FiO2 post prone in day 2 [Post prone in day 2]

      Patients' response of oxygenation using SpO2/FiO2

    5. SpO2/FiO2 pre prone in day 3 [Pre prone in day 3]

      Patients' response of oxygenation using SpO2/FiO2

    6. SpO2/FiO2 post prone in day 3 [Post prone in day 3]

      Patients' response of oxygenation using SpO2/FiO2

    7. Lung Ultrasound Score pre prone in day 1 [Pre prone in day 1]

      Patients' response of oxygenation using Lung ultrasound score

    8. Lung Ultrasound Score post prone in day 1 [Post prone in day 1]

      Patients' response of oxygenation using Lung ultrasound score

    9. Lung Ultrasound Score pre prone in day 2 [Pre prone in day 2]

      Patients' response of oxygenation using Lung ultrasound score

    10. Lung Ultrasound Score post prone in day 2 [Post prone in day 2]

      Patients' response of oxygenation using Lung ultrasound score

    11. Lung Ultrasound Score pre prone in day 3 [Pre prone in day 3]

      Patients' response of oxygenation using Lung ultrasound score

    12. Lung Ultrasound Score post prone in day 3 [Post prone in day 3]

      Patients' response of oxygenation using Lung ultrasound score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. Adult subjects 18 years and older,

    2. Confirmed COVID-19 diagnosis

    3. Acute hypoxemic respiratory failure (SpO2/FiO2 or PaO2/FiO2 <300)

    4. Ordered self-prone positioning per medical team

    Exclusion Criteria:
    1. Pregnant

    2. Palliative care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rush University Medical Center Chicago Illinois United States 60612
    2 Hospital Civil Fray Antonio Alcalde Guadalajara Jalisco Mexico 44280

    Sponsors and Collaborators

    • Rush University Medical Center
    • Hospital Civil de Guadalajara

    Investigators

    • Principal Investigator: Jie Li, Rush University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jie Li, Associate Professor, Rush University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04855162
    Other Study ID Numbers:
    • 21040601
    First Posted:
    Apr 22, 2021
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jie Li, Associate Professor, Rush University Medical Center

    Study Results

    No Results Posted as of Nov 15, 2021