NCT06716502

A New Portable Device for Non-invasive Ventilatory Support

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy
• Respiratory Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-17
• Primary completion: 2026-04-01
• Completion: 2026-05-19
• First posted: 2024-12-04
• Last updated: 2026-03-20

Locations

3 sites across 1 country: Italy