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Stability of Driving Pressure Changes During "Best Positive End Expiratory Pressure (PEEP)" Trial

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05958862
Collaborator
(none)
50
Enrollment
17.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this study is to better understand in changes in lung compliance as indicated by driving pressure (a non-invasive marker) following changes in positive end expiratory pressure (PEEP; a standard of care ventilator parameter).

The main question it aims to answer is: The time to stability of driving pressure after a change in PEEP is made Type of study: observational study participant population/health conditions

Participants will undergo a "best PEEP trial" which is a standard intensive care intervention for patients undergoing invasive mechanical ventilation. This involves changing the patient's PEEP and looking for response in driving pressure. This will be done in a more protocolized format and data will be collected.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Stability of Driving Pressure Changes During "Best Positive End Expiratory Pressure (PEEP)" Trial
    Anticipated Study Start Date :
    Jan 1, 2024
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Jun 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Stability of change in Driving Pressure after PEEP manipulation [10 minutes total]

      Our study attempts to find the time point when driving pressure reaches stability. The primary outcome will be the first time point (3 breaths, 30 seconds, 1 minute, 3 minutes, 5 minutes, 10 minutes) where driving pressure is not statistically different from the baseline measurement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult patients >18 years of age

    • Undergoing intubation and mechanical ventilation in Medical Intensive Care Unit (MICU) or Medical Critical Care Unit (MCCU) at the University of Alabama Birmingham.

    Exclusion Criteria:

    • Prisoner

    • Pregnant

    • Age <18 years of age

    • Intensive Care Unit (ICU) team declines participation

    • Unstable oxygenation (requiring 100% FiO2 to maintain saturations greater than 90% oxygen saturation following initial PEEP titration by primary team)

    • Hemodynamic instability: vasopressor requirement of >0.3 mcg/kg/min of norepinephrine or equivalent

    • Pneumomediastinum

    • Pneumothorax without chest tube

    • Previous enrolled in trial

    • Need for immediate travel out of ICU following intubation for procedures, tests

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: Ryan L Goetz, MD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Ryan L. Goetz, Pulmonary and Critical Care Medicine Fellow, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT05958862
    Other Study ID Numbers:
    • IRB-300010038
    First Posted:
    Jul 25, 2023
    Last Update Posted:
    Jul 25, 2023
    Last Verified:
    Jul 1, 2023
    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
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Respiratory Insufficiency
    Acute Lung Injury

    Study Results

    No Results Posted as of Jul 25, 2023