Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03793842
Collaborator
(none)
16
1
2
39.7
0.4

Study Details

Study Description

Brief Summary

Doctors follow a standard ventilator management strategy when making adjustments to the breathing machine to optimize the amount of oxygen into the lungs. The purpose of this study is to assess whether the EIT (electrical impedance tomography) device can be an additional useful tool for ventilator management and identifying the ideal positive end-expiratory pressure (PEEP).

Condition or Disease Intervention/Treatment Phase
  • Other: Usual care
  • Device: PEEP titration by EIT
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome
Actual Study Start Date :
Mar 4, 2019
Actual Primary Completion Date :
Jun 24, 2022
Actual Study Completion Date :
Jun 24, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Usual care then PEEP titration by EIT

Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan ARDS protocol high-PEEP arm

Other: Usual care
Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.

Device: PEEP titration by EIT
PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
Other Names:
  • Drager PulmoVista 500 EIT System
  • Experimental: PEEP titration by EIT then usual care

    Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.

    Other: Usual care
    Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.

    Device: PEEP titration by EIT
    PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
    Other Names:
  • Drager PulmoVista 500 EIT System
  • Outcome Measures

    Primary Outcome Measures

    1. Change in lung inflammation as measured by physiologic parameter: Mechanical Power [Up to 24 hours]

      Physiological parameter

    Secondary Outcome Measures

    1. Change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen (PaO2) [Up to 24 hours]

      Physiologic parameter

    2. Change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen/Fraction of Inspired Oxygen (P/F ratio) [Up to 24 hours]

      Physiologic parameter

    3. Change in lung inflammation as measured by physiologic parameter: Plateau pressure [Up to 24 hours]

      Physiologic parameter

    4. Lung inflammation as measured by physiologic parameter: Driving Pressure [Up to 24 hours]

      Physiologic parameter

    5. Change in lung inflammation as measured by physiologic parameter: Static compliance [Up to 24 hours]

      Physiologic parameter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Endotracheal ventilation for < 1 week (168 hours)

    • Presence of all of the following conditions for < 48 hours i. PaO2/FiO2 < 150 with PEEP > 5 cm H2O for > 30 min. ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload

    • All criteria listed in (3) developed within 1 week of a known clinical insult or new or worsening respiratory symptoms

    Exclusion Criteria:
    • Lack of informed consent

    • Known pregnancy

    • ECMO

    • Severe chronic respiratory disease requiring home oxygen therapy or ventilation

    • Calculated BMI of greater than 50

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Robert Hyzy, MD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert C. Hyzy, MD, Professor of Internal Medicine, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT03793842
    Other Study ID Numbers:
    • HUM00148126
    First Posted:
    Jan 4, 2019
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    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:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Robert C. Hyzy, MD, Professor of Internal Medicine, University of Michigan
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 29, 2022