A New Portable Device for Non-invasive Ventilatory Support
A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
Università Vita-Salute San Raffaele
50 participants
Sep 17, 2025
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
Inclusion Criteria8
- Arm 1
- Age ≥65 years
- Clinically stable: non-hospitalized and not in acute illness
- no professional medical knowledge: no experience as a health care provider
- Ability to express informed consent as requested by the ethical committee
- Hospitalized adult patient
- SpO2 of 90-93% in room air
- Arm 2
Exclusion Criteria9
- Arm 2
- Facial burns/trauma/recent facial or upper airway surgery
- Vomiting
- Fixed upper airway obstruction
- Undrained pneumothorax
- Recent upper gastrointestinal surgery
- Inability to protect the airway
- Bowel obstruction
- Patient refusal
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06716502