Assessing breathing effort and lung expansion during non-invasive ventilation
Noninvasive Assessment of Inspiratory Effort and Tidal Distension During Noninvasive Ventilation. The INSPIRE Study.
University of Bari · NCT06344234
This study is trying to see how well certain breathing tests can help understand how hard hypoxemic patients are working to breathe while using non-invasive ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bari (other) |
| Locations | 1 site (Bari) |
| Trial ID | NCT06344234 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the correlation between airway occlusion pressure and esophageal pressure swings in hypoxemic patients undergoing non-invasive ventilation (NIV). It will assess the reliability of various noninvasive measures, such as P0.1 and diaphragm ultrasound, to estimate inspiratory effort and lung distension. The study will involve end-inspiratory maneuvers to gather data on these parameters. By analyzing these relationships, the study seeks to improve the understanding of respiratory mechanics in patients receiving NIV.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are hypoxemic and monitored through esophageal pressure before extubation.
Not a fit: Patients with severe facial trauma, neuromuscular disorders, or acute exacerbations of COPD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of respiratory diseases by providing reliable noninvasive methods to assess breathing effort and lung expansion.
How similar studies have performed: While similar approaches have been explored, this specific correlation and methodology may provide novel insights into non-invasive ventilation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than or equal to 18 years. * Non-pregnant and non-lactating. * Monitored through esophageal pressure for clinical decision before extubation. * Able to provide written informed consent to participate in the study. Exclusion Criteria: * Patients with severe facial trauma or deformity that precludes the placement of a facemask or esophageal catheter. * Patients with neuromuscular disorders that may impair inspiratory drive and effort. * Patients with acute exacerbation of COPD * Patients with esophageal or tracheal abnormalities that impede esophageal manometry. * Patients with a known hypersensitivity or allergy to any of the materials used in the study. * Excessive air leak (difference between inspiratory and expiratory tidal volume major or equal to 10%)
Where this trial is running
Bari
- Azienda ospedaliero-universitaria consorziale policlinico di Bari — Bari, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesco Murgolo, MD
- Email: salvatore.grasso@uniba.it
- Phone: ++393923688291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Disease, Artificial Respiration, noninvasive ventilation, respiration, artificial, Ventilators, Mechanical, Positive End-Expiratory Pressure