Personalized Noninvasive Support
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 2, 2024
Trial Information
Current as of August 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring the best noninvasive ways to help patients with a serious breathing condition called acute hypoxemic respiratory failure. In this study, researchers want to find out how different types of breathing support—specifically, pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP)—affect how hard patients have to work to breathe. They believe that these methods can help patients breathe better, but they want to see which option might be more effective based on how much effort each individual needs to put into breathing.
To be eligible for this trial, participants should be between 65 and 74 years old and have a specific level of low oxygen in their blood. They should not have breathing problems caused by chronic lung disease, heart failure, or too much fluid in the body. Patients who are pregnant, recently had certain surgeries, or have specific health issues like a collapsed lung cannot participate. If you join this study, you can expect to receive personalized breathing support tailored to your needs, and you'll help researchers learn more about the best ways to treat this condition.
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 support
- • 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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported