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A New Portable Device for Non-invasive Ventilatory Support
Sponsor: Università Vita-Salute San Raffaele
Summary
Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population. The efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.
Official title: A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-09-17
Completion Date
2026-05-19
Last Updated
2026-03-20
Healthy Volunteers
Yes
Conditions
Interventions
Portable CPAP efficacy
The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O
Portable CPAP usability assessment
The device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.
Locations (3)
Città di Lecce Hospital
Lecce, Apulia, Italy
IRCCS San Raffaele
Milan, Italy
Università degli studi di Verona
Verona, Italy