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Search / Trial NCT06344234

Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE)

Launched by UNIVERSITY OF BARI · Mar 27, 2024

Trial Information

Current as of May 21, 2025

Recruiting

Keywords

Noninvasive Ventilation Respiration, Artificial Ventilators, Mechanical Positive End Expiratory Pressure

ClinConnect Summary

The INSPIRE trial is studying how well certain non-invasive methods can measure the effort a patient uses to breathe when they are on non-invasive ventilation (NIV) due to respiratory disease. Specifically, the researchers want to see if a specific airway pressure measurement taken during a brief pause in breathing is related to the pressure changes in the esophagus, which can indicate how hard the patient is breathing. They will also look at other measurements, like diaphragm movement and the amount of air a person can take in, to see how reliable these methods are in understanding a patient's breathing effort and lung expansion.

To participate in this study, individuals must be 18 years or older and able to provide consent. They should be undergoing monitoring with an esophageal pressure catheter as part of their routine care. However, people with certain conditions, such as severe facial injuries or neuromuscular disorders, may not be eligible. Participants will go through a series of tests while on NIV, including breathing assessments and ultrasound imaging of the diaphragm to gather data. The study is currently recruiting and aims to improve our understanding of respiratory support for patients in need.

Gender

ALL

Eligibility 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%)

About University Of Bari

The University of Bari, a prestigious academic institution located in Bari, Italy, is dedicated to advancing medical research and education. With a strong emphasis on innovation and interdisciplinary collaboration, the university conducts clinical trials aimed at improving patient outcomes and contributing to the global body of medical knowledge. Leveraging its expertise in various fields of healthcare, the University of Bari fosters an environment that prioritizes ethical practices, scientific rigor, and the development of new therapeutic strategies, ultimately enhancing the quality of life for diverse patient populations.

Locations

Bari, , Italy

Patients applied

0 patients applied

Trial Officials

Salvatore Grasso, Prof

Study Chair

Azienda Ospedaliero-Universitaria "Consorziale Policlinico" Bari

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported