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Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05778292
Collaborator
(none)
15
Enrollment
1
Location
24
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the feasibility of using electric impedance tomography (EIT) to monitor lung perfusion during veno-venous (VV) extracopreal membrane oxygenation (ECMO) support, as well as the effect of different ECMO flows on lung perfusion monitored by EIT.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a monocentric obsevensional study that uses EIT to monitor lung perfusion during VV ECMO support and the effect of different ECMO flows on lung perfusion as measured by EIT. Patients on VV ECMO who meet the withdrawal criteria as determined by clinical experts will have their ECMO flow gradually reduced. EIT lung ventilation and perfusion monitoring were performed at various ECMO flows.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT: an Observational Study
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Lung perfusion at different VV ECMO flows [up to 24hour]

      Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung perfusion distribution Monitored by EIT

    Secondary Outcome Measures

    1. Lung ventilation at different VV ECMO flows [up to 24hour]

      Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung ventilation distribution monitored by EIT

    2. Lung deadspace region at different VV ECMO flows [up to 24hour]

      Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung deadspace region monitored by EIT

    3. Lung shunt region at different VV ECMO flows [up to 24hour]

      Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung shunt region monitored by EIT

    4. Lung ventilation/perfusion matching at different VV ECMO flows [up to 24hour]

      Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung ventilation/perfusion matching monitored by EIT

    5. Recirculation at different VV ECMO flows [up to 24hour]

      Recirculation at different VV ECMO flows (ECMO flow at 4.5L,3.5L,2.5L,and1.5L)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients aged ≥ 18 and ≤ 70 years；

    2. Patients supported with VV ECMO for respiratory failure；

    3. Patients are intubated and mechanically ventilated.

    Exclusion Criteria:

    1. EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;

    2. Patients who did not sign the informed consent form;

    3. Pulmonary embolism;

    4. Pneumothorax;

    5. Medium to plenty of chest water;

    6. Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;

    7. Refractory shock;

    8. Severe chronic heart and lung disease has existed in the past;

    9. BMI>35 kg/m2;

    10. Intra-abdominal pressure >20mmHg.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xiaobo Yang Wuhan Hubei China 430022

    Sponsors and Collaborators

    • Wuhan Union Hospital, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaobo Yang, MD, Clinical Professor, Wuhan Union Hospital, China
    ClinicalTrials.gov Identifier:
    NCT05778292
    Other Study ID Numbers:
    • ECMO20221119
    First Posted:
    Mar 21, 2023
    Last Update Posted:
    Mar 21, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiaobo Yang, MD, Clinical Professor, Wuhan Union Hospital, China
    VV ECMO
    EIT
    Lung perfusion
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Mar 21, 2023