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Search / Trial NCT06210386

Physiology of Helmet vs. Facemask Noninvasive Ventilation

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 15, 2024

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different types of noninvasive ventilation methods—using a helmet versus a facemask—to see which one works better for patients with acute hypoxemic respiratory failure, a condition where the lungs cannot get enough oxygen. Researchers want to find out if the helmet can provide better support and comfort for patients while allowing higher pressure levels without air leaks, compared to the facemask.

To participate in the study, you should be between 65 and 74 years old and have a specific type of respiratory failure that meets certain medical criteria. If you qualify, you'll be randomly assigned to try both the helmet and the facemask at different settings, allowing researchers to observe how each method affects your breathing. It's important to know that some people may not be eligible due to certain health conditions or recent surgeries. This study is currently looking for participants, and it could help improve care for patients experiencing similar breathing difficulties in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Acute hypoxemic respiratory failure and PaO2/FiO2\<200 mmHg
  • PaCO2\<45 mmHg
  • Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload
  • Exclusion Criteria:
  • Pregnancy
  • Contraindication to helmet or facemask noninvasive ventilation
  • Contraindication to esophageal manometry
  • Contraindication to electrical-impedance tomography monitoring
  • Recent surgery involving the abdomen or the thorax
  • Pneumothorax or documented barotrauma

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, , Italy

Patients applied

0 patients applied

Trial Officials

Domenico L. Grieco, MD

Principal Investigator

Fondazione Policlinico A. Gemelli IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported