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

Idiopathic Pulmonary Fibrosis Clinical Trial

— ETROPON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098717
• Other study ID #: UModenaReggio11
• Status: Recruiting
• Start date: February 8, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: University of Modena and Reggio Emilia
• Contact: Roberto Tonelli
• Phone: 0039 0594225934
• Email: roberto.tonelli[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Mechanical Ventilation Pressure High
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Policlinico di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung elastance	The effect of PEEP titration according to end-expiratory transpulmonary pressure on lung elastance will be analyzed.	2 hours.
Secondary	P/F ratio	The effect of PEEP titration according to end-expiratory transpulmonary pressure on P/F ratio will be analyzed.	2 hours