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RECRUITING
NCT06716502
NA

A New Portable Device for Non-invasive Ventilatory Support

Sponsor: Università Vita-Salute San Raffaele

View on ClinicalTrials.gov

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

Interventions

DEVICE

Portable CPAP efficacy

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

DEVICE

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