RecruitingNot ApplicableNCT06716502

A New Portable Device for Non-invasive Ventilatory Support

A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure


Sponsor

Università Vita-Salute San Raffaele

Enrollment

50 participants

Start Date

Sep 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Portable CPAP efficacy and a medical device called Portable CPAP usability assessment for people with healthy and respiratory disease. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPortable CPAP efficacy

The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O

DEVICEPortable 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

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NCT06716502


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