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

NCT05098717 | Recruiting

• 1 other identifier: UModenaReggio11
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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,

Conditions

Idiopathic Pulmonary Fibrosis; Mechanical Ventilation Pressure High

Outcome Measures

Primary Outcomes (1)

• Lung elastance

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

  2 hours.

Secondary Outcomes (1)

• P/F ratio

  2 hours

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• chest wall deformities
• chronic obstructive pulmonary disease

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Italy

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Roberto Tonelli

CONTACT

0039 0594225934; roberto.tonelli@me.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: February 8, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

IT (1)