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

NCT ID: NCT05098717

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-08

Study Completion Date

2027-01-01

Brief Summary

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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

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Conditions

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Idiopathic Pulmonary Fibrosis Mechanical Ventilation Pressure High

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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UIP patients

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

No interventions assigned to this group

ARDS patients

Patients with ARDS undergoing mechanical ventilation for acute respiratory failure

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Modena and Reggio Emilia

OTHER

Sponsor Role lead

Responsible Party

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Roberto Tonelli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Roberto Tonelli

Role: CONTACT

0039 0594225934

Facility Contacts

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Roberto Tonelli

Role: primary

Other Identifiers

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UModenaReggio11

Identifier Type: -

Identifier Source: org_study_id

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