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

March 14, 2024 updated by: Roberto Tonelli, University of Modena and Reggio Emilia
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,

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Modena, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico di Modena
        • Contact:
          • Roberto Tonelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with lung fibrosis and UIP pattern undergoing esophageal manometry and controlled mechanical ventilation for acute respiratory failure admitted to the Intensive Care Unit and Respiratory Intensive Care Unit of the University Hospital of Modena that will fulfill the eligibility criteria will be enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung elastance
Time Frame: 2 hours.
The effect of PEEP titration according to end-expiratory transpulmonary pressure on lung elastance will be analyzed.
2 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P/F ratio
Time Frame: 2 hours
The effect of PEEP titration according to end-expiratory transpulmonary pressure on P/F ratio will be analyzed.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UModenaReggio11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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