ETROPON: End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation

Sponsor
University of Modena and Reggio Emilia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05098717
Collaborator
(none)
40
1
24
1.7

Study Details

Study Description

Brief Summary

Patients with pulmonary fibrosis and associated usual interstitial pneumonia that require mechanical ventilation for acute respiratory failure experience poor clinical outcomes. This may be influenced by the unfavorable interaction between the fibrotic lung and the stress and strain stimuli generated during controlled ventilation. Although there is no consensus on how to ventilate these patients, much of the recommendations followed in clinical practice are taken from the experience on patients with acute respiratory distress syndrome. Among these, measuring the esophageal pressures and adjusting positive-end expiatory pressure to make trans-pulmonary pressures positive can decrease atelectasis, derecruitment of lung, and cyclical opening and closing of airways and alveoli, thus optimizing lung mechanics and oxygenation. The effect of this strategy on the fibrotic lung has not yet been documented. With this observational study we aim at documenting the effect of PEEP titration maneuver based on end-expiratory trans-pulmonary pressure on lung mechanics of patients with pulmonary fibrosis and UIP pattern,

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    UIP patients

    Patients with pulmonary fibrosis and UIP pattern undergoing mechanical ventilation for acute respiratory failure

    ARDS patients

    Patients with ARDS undergoing mechanical ventilation for acute respiratory failure

    Outcome Measures

    Primary Outcome Measures

    1. Lung elastance [2 hours.]

      The effect of PEEP titration according to end-expiratory transpulmonary pressure on lung elastance will be analyzed.

    Secondary Outcome Measures

    1. P/F ratio [2 hours]

      The effect of PEEP titration according to end-expiratory transpulmonary pressure on P/F ratio will be analyzed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • pulmonary fibrosis with UIP pattern

    • subjected to endotracheal intubation and controlled mechanical ventilation for acute respiratory failure

    • candidate to a trial of PEEP titration according to positive end expiratory pressure.

    Exclusion Criteria:
    • chest wall deformities

    • chronic obstructive pulmonary disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliero Universitaria Policlinico di Modena Modena Italy

    Sponsors and Collaborators

    • University of Modena and Reggio Emilia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roberto Tonelli, Principal Investigator, University of Modena and Reggio Emilia
    ClinicalTrials.gov Identifier:
    NCT05098717
    Other Study ID Numbers:
    • UModenaReggio11
    First Posted:
    Oct 28, 2021
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 23, 2022