Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography

Sponsor
Osaka University (Other)
Overall Status
Completed
CT.gov ID
NCT04473300
Collaborator
Hospital Rebagliati (Other)
43
1
9.6
4.5

Study Details

Study Description

Brief Summary

Novel coronavirus (SARS-CoV-2: severe acute respiratory coronavirus 2) pneumonia often develop the acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy consisting of low tidal volume and high positive end-expiratory pressure (PEEP) is recommended. However, it is not clear whether injured lungs from SARS-CoV-2 pneumonia have the same mechanical properties, especially response to PEEP as common ARDS. Therefore, the investigators propose an observational study to analyze respiratory mechanics and lung recruitablity using EIT (electrical impedance tomography) in patients with ARDS due to SARS-CoV-2 pneumonia.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The multi-center prospective observational study will enroll 20 adult ARDS patients under mechanical ventilation from Intensive Care Units (ICUs) in Japan and Peru. Informed consent will be waived due to the nature of observational study. Patients with positive SARS-CoV-2 infection will be included. Prior to initiating the protocol, patients will be sedated deeply with sedatives and/or opioids and paralyzed with a continuous infusion of rocuronium. The distribution of ventilation will be evaluated with EIT.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    43 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study
    Actual Study Start Date :
    May 11, 2020
    Actual Primary Completion Date :
    Feb 28, 2021
    Actual Study Completion Date :
    Feb 28, 2021

    Outcome Measures

    Primary Outcome Measures

    1. The distribution of ventilation [Through study completion (up to 24 hours)]

      The distribution of ventilation measured by EIT at PEEP 5 and 15.

    Secondary Outcome Measures

    1. Silent spaces [Through study completion (up to 24 hours)]

      The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.

    2. Respiratory system compliance [Through study completion (up to 24 hours)]

      Respiratory system compliance in PEEP 5 and 15.

    3. Oxygenation [Through study completion (up to 24 hours)]

      Oxygenation in PEEP 5 and 15.

    4. Dead space ventilation ratio [Through study completion (up to 24 hours)]

      Dead space ventilation ratio in PEEP 5 and 15.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients with positive SARS-CoV-2 infection*

    2. Patients with ARDS under mechanical ventilation**

    3. Patients ≧ 18 years old

    • Definition of SARS-CoV-2 infection positive: SARS-CoV-2 infection is defined as being positive in RT-PCR (real time reverse transcriptase-polymerase chain reaction) assay using nasal or pharyngeal swab samples.

    • Definition of ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 300 mmHg with PEEP ≧ 5 cmH2O)

    Exclusion Criteria:
    1. Contraindication for EIT monitoring

    2. Unstable spine or pelvic fractures

    3. Pacemaker, automatic implantable cardioverter defibrillator

    4. Skin lesions between the 4th and 5th ribs where the EIT belt is worn

    5. Home mechanical ventilation before inclusion

    6. Pregnancy

    7. DNR (do-not-resuscitate)

    8. Increased intracranial pressure (> 18 mmHg)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka University Hospital Suita Osaka Japan 565-0871

    Sponsors and Collaborators

    • Osaka University
    • Hospital Rebagliati

    Investigators

    • Principal Investigator: Takeshi Yoshida, M.D., Ph.D., Osaka University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osaka University
    ClinicalTrials.gov Identifier:
    NCT04473300
    Other Study ID Numbers:
    • ASPEIT
    First Posted:
    Jul 16, 2020
    Last Update Posted:
    Jul 1, 2021
    Last Verified:
    Jul 1, 2020
    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 Osaka University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 1, 2021