Idiopathic Pulmonary FibrosisETROPONNCT05098717
End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation
An observational study of Idiopathic Pulmonary Fibrosis and Mechanical Ventilation Pressure High, run by University of Modena and Reggio Emilia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Mechanical Ventilation Pressure High
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- chest wall deformities
- chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena
Roberto Tonelli
About this study
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,
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Lung elastance
The effect of PEEP titration according to end-expiratory transpulmonary pressure on lung elastance will be analyzed.
Measured: 2 hours.
Secondary outcomes (1)
P/F ratio
The effect of PEEP titration according to end-expiratory transpulmonary pressure on P/F ratio will be analyzed.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start8 Feb 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Tonelli, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098717
- Sponsor's protocol ID
- UModenaReggio11
- Acronym
- ETROPON
- Status last verified
- Apr 2025
- First submitted
- 15 Oct 2021
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05098717
- Acronym / sponsor ID
- ETROPON / UModenaReggio11
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- chest wall deformities
- chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung elastance
Time frame: 2 hours.
The effect of PEEP titration according to end-expiratory transpulmonary pressure on lung elastance will be analyzed.
1 secondary outcome
P/F ratio
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Mechanical Ventilation Pressure High, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Tonelli (0039 0594225934, roberto.tonelli@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung elastance (time frame: 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.