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

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis; Mechanical Ventilation Pressure High

• Registration Number: NCT05098717
• Lead Sponsor: University of Modena and Reggio Emilia

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,

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-28
• Study Start: 2023-02-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung elastance	2 hours.	The effect of PEEP titration according to end-expiratory transpulmonary pressure on lung elastance will be analyzed.

Secondary Outcome Measures

Name	Time	Method
P/F ratio	2 hours	The effect of PEEP titration according to end-expiratory transpulmonary pressure on P/F ratio will be analyzed.

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Policlinico di Modena; 🇮🇹 Modena, Italy