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Ventiltion and Esophageal Pressure Changes

Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT05859672
Collaborator
(none)
150
Enrollment
1
Location
18.5
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to observe the effect of variations in ventilator settings including tidal volume and PEEP on transpulmonary pressure monitored with an esophageal balloon catheter and to correlate intraoperative transpulmonary pressure variations and intraoperative stroke volume variation changes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study seeks to observe the effects of variations in ventilator settings on transpulmonary and intrathoracic pressures. More specifically, to observe the impact of variations in tidal volume from 6 mL/kg to 8 mL/kg and PEEP from 0 cm H2O to 5 cm H2O on transpulmonary and intrathoracic pressures monitored with an esophageal balloon catheter. The impact of this recommended decrease in tidal volume on the clinical utility of SVV as a guide for fluid administration has not been previously examined.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    A Study of Intraoperative Transpulmonary and Intrathoracic Pressure Changes Associated With Ventilator Management of Tidal Volume and Positive End-expiratory Pressure (PEEP)
    Actual Study Start Date :
    Jun 16, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Intrathoracic Pressure [Intra-operative]

      Measure the intrathoracic pressure changes monitored with an esophageal pressure balloon catheter associated with intraoperative changes in mechanical ventilation parameters such as tidal volume and PEEP

    Secondary Outcome Measures

    1. Stroke Volume Variation [Intra-operative]

      Characterizing the changes in SVV associated with intraoperative changes in mechanical ventilation parameters such as tidal volume and PEEP and the correlations with changes in intrathoracic pressure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation.

    • Age ≥ 18

    Exclusion Criteria:

    • Patients undergoing planned esophageal surgery

    • Patients with significant nasal or esophageal pathology

    • Adults unable to consent

    • Individuals who are not yet adults (infants, children, teenagers)

    • Pregnant women

    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC Davis Medical Center Sacramento California United States 95817

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

    • Principal Investigator: Neal Fleming, MD, PhD, University of California, Davis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Neal Fleming, MD, PhD, Clinical Professor, University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT05859672
    Other Study ID Numbers:
    • 1903822
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 16, 2023