A New Portable Device for Non-invasive Ventilatory Support

Recruiting now · Not applicable

Conditions studied: Healthy, Respiratory Disease

In brief

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.

Key facts

Study ID

NCT06716502

Run by

Università Vita-Salute San Raffaele

People needed

50

Starts

2025-09-17

Expected to finish

2026-06-19

Last updated by the study team

2026-05-06

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Arm 1 Exclusion Criteria: none
• Arm 2
• Inclusion Criteria:
• Hospitalized adult patient
• SpO2 of 90-93% in room air
• Arm 2

You may not qualify if…

• 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

Where it is running

• IRCCS San Raffaele — Milan, Italy (enrolling)
• Città di Lecce Hospital — Lecce, Apulia, Italy
• Università degli studi di Verona — Verona, Italy

Full record on ClinicalTrials.gov

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