A portable, easy-to-use CPAP device for non-invasive breathing support.
A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
This will test a new portable CPAP device to see if older adults and hospitalized patients with low oxygen can use it easily and whether it helps them breathe better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 3 sites (Lecce, Apulia and 2 other locations) |
| Trial ID | NCT06716502 on ClinicalTrials.gov |
What this trial studies
This multicenter study in three Italian hospitals will test the performance and usability of a portable CPAP device designed for out-of-hospital first-aid use. It includes two arms: usability testing in clinically stable adults aged 65 and older without medical training, and clinical testing in hospitalized adults with SpO2 of 90-93% on room air. Investigators will collect device performance data and user-feedback to judge ease of use and short-term respiratory support. Results are intended to inform future deployment of the device in real-world pre-hospital settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older without healthcare training for usability testing, and hospitalized adults with mild hypoxemia (SpO2 90-93%) for clinical performance testing who can provide informed consent.
Not a fit: Patients with contraindications such as facial trauma or recent upper airway surgery, vomiting, undrained pneumothorax, inability to protect the airway, bowel obstruction, or those requiring immediate invasive ventilation are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could enable earlier, wider use of CPAP outside hospitals and help reduce deaths and complications from acute respiratory failure.
How similar studies have performed: CPAP delivered by healthcare providers has improved outcomes in respiratory failure, but portable devices explicitly designed for lay or first-aid users have been largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Arm 1 Inclusion Criteria: 1. Age ≥65 years 2. Clinically stable: non-hospitalized and not in acute illness 3. no professional medical knowledge: no experience as a health care provider 4. Ability to express informed consent as requested by the ethical committee Arm 1 Exclusion Criteria: none Arm 2 Inclusion Criteria: 1. Hospitalized adult patient 2. SpO2 of 90-93% in room air Arm 2 Exclusion Criteria: 1. Facial burns/trauma/recent facial or upper airway surgery 2. Vomiting 3. Fixed upper airway obstruction 4. Undrained pneumothorax 5. Recent upper gastrointestinal surgery 6. Inability to protect the airway 7. Bowel obstruction 8. Patient refusal
Where this trial is running
Lecce, Apulia and 2 other locations
- Città di Lecce Hospital — Lecce, Apulia, Italy (Not_yet_recruiting)
- IRCCS San Raffaele — Milan, Italy (Recruiting)
- Università degli studi di Verona — Verona, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Giovanni Landoni, MD
- Email: landoni.giovanni@hsr.it
- Phone: +39 022643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.