A portable, easy-to-use CPAP device for non-invasive breathing support.
Official title: A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
Run by Università Vita-Salute San Raffaele · NCT06716502 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 3 sites (Lecce, Apulia and 2 other locations) |
| Status | Recruiting |
| Started | September 17, 2025 |
| Main results expected | May 19, 2026 |
| Study ends | June 19, 2026 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT06716502 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
IRCCS San Raffaele
Milan, Italy Recruiting -
Città di Lecce Hospital
Lecce, Apulia, Italy Not yet 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.