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A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
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.
The efficacy and usability of a new portable CPAP device will be assessed in different clinical settings. The study will take place in three hospitals in Italy, with the objective of collecting data to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Città di Lecce Hospital
Lecce, Apulia, Italy
IRCCS San Raffaele
Milan, Italy
Università degli studi di Verona
Verona, Italy
Start Date
September 17, 2025
Primary Completion Date
April 1, 2026
Completion Date
May 19, 2026
Last Updated
March 20, 2026
50
ESTIMATED participants
Portable CPAP efficacy
DEVICE
Portable CPAP usability assessment
DEVICE
Lead Sponsor
Università Vita-Salute San Raffaele
Collaborators
NCT06290258
NCT00090662
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07310264