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Active, not recruitingNCT05313672IERATICUpdated Apr 25, 2025

Inspiratory Effort and Respiratory Mechanics in Spontaneously Breathing Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Matched Control Study

An observational study in Idiopathic Pulmonary Fibrosis, sponsored by Roberto Tonelli. Active, not recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Roberto Tonelli · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

Idiopathic pulmonary fibrosis is a life-threatening lung disease characterized by progressive deterioration of lung function and a median survival time of 3-5 years from diagnosis. The onset of an acute deterioration (AE) of respiratory function, the so called acute exacerbation of IPF (AE-IPF), may lead to severe hypoxemia, further worsening prognosis. During these events, the typical usual interstitial pneumonia pattern (UIP) - the radiologic and histologic hallmark of IPF- is overlapped with diffuse alveolar damage (DAD), sharing similarities with the acute respiratory distress syndrome (ARDS) and often requiring respiratory assistance. Several studies show that the need for mechanical ventilation (MV) is associated with high mortality in IPF patients, probably due to the pathophysiological properties of UIP-like fibrotic lung (i.e. collapse induration areas, elevated lung elastance, high inhomogeneity) that make it more susceptible to ventilatory-induced lung injury (VILI). It has been theorized that the application of PEEP on a UIP-like lung pattern can determine the protrusion of the most distensible areas through a dense anelastic fibrotic tissue circles, causing increased rigidity, worsening compliance, and thus enabling tissue breakdown. In this scenario, non-invasive mechanical ventilation (NIV) may therefore represent an alternative option to assist these patients, although no specific recommendations have been made so far. In patients with ARDS, the efficacy of NIV in reducing the patient's inspiratory effort early after its application has been related to a favorable clinical outcome. Indeed, the mitigation of respiratory drive might have resulted in a lower risk for the self-inflicted lung injury (SILI) during spontaneous breathing, whose onset is very likely to worse outcomes of patients undergoing acute respiratory failure (ARF).

To date no data available on the inspiratory effort and the lung mechanics in patients with AE-IPF either during unassisted of assisted spontaneous breathing. Aim of this study was then to compare respiratory mechanics, at baseline and 2-h following NIV application, in AE-IPF and ARDS patients matched for severity.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • Inspiratory effort
  • Esophageal manometry
  • Non-invasive mechanical ventilation
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 20 is below the median of 130 across 229 observational studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

This is the only study on the registry with Roberto Tonelli as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with IPF developing AE consecutively admitted to the Respiratory Intensive Care Unit and the Intensive Care Unit of the University Hospital of Modena over the period August 1st, 2016 to January 1th, 2022 were prospectively considered eligible for enrollment.

Inclusion criteria

previously established diagnosis of IPF; occurring acute exacerbation of IPF as defined by an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality on chest CT scan (12); age >18 years; presence of ARF with PaO2/FiO2 ratio \<200 mmHg despite HFNC (set with at least 60 L/min and FiO2 higher than 0.6); suitability for a NIV trial according to the attending staff; consent to measure esophageal pressure.

Exclusion criteria

Exclusion Criteria:

  • acute cardiogenic pulmonary edema,
  • concomitant hypercapnic respiratory failure (PaCO2 >45 mmHg) of any etiology,
  • neuromuscular disease or chest wall deformities,
  • home long-term oxygen therapy,
  • intolerance or contraindication to NIV, such as the need for immediate endotracheal intubation
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • IPF patients with UIP pattern requiring NIV
  • ARDS patients requiring NIV
06

What researchers measure

Primary outcomes

  1. Inspiratory effort in IPF patients

    Assessment of esophageal pressure swing in IPF patients during acute exacerbation of disease as compared to ARDS

    Time frame: On respiratory intensive care unit admission

Secondary outcomes

  1. Respiratory mechanics change after NIV application in IPF patients acute exacerbation

    Respiratory mechanics change after NIV application in IPF patients acute exacerbation as compared to ARDS

    Time frame: 2 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05313672
Lead sponsor
Roberto Tonelli
Responsible party
Roberto Tonelli (Principal investigator, University of Modena and Reggio Emilia) — Sponsor-investigator
First posted
Apr 6, 2022
Start date
Aug 1, 2016
Primary completion
Apr 1, 2022
Completion
Aug 1, 2026 (estimated)
Last update
Apr 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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