NCT06716502 A New Portable Device for Non-invasive Ventilatory Support
| NCT ID | NCT06716502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Università Vita-Salute San Raffaele |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2026-05-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-09-17 with a primary completion date of 2026-05-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Giovanni Landoni, MD
STUDY CHAIR
IRCCS San Raffaele
Frequently Asked Questions
Who can join the NCT06716502 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06716502 currently recruiting?
Yes, NCT06716502 is actively recruiting participants. Contact the research team at landoni.giovanni@hsr.it for enrollment information.
Where is the NCT06716502 trial being conducted?
This trial is being conducted at Lecce, Italy, Milan, Italy, Verona, Italy.
Who is sponsoring the NCT06716502 clinical trial?
NCT06716502 is sponsored by Università Vita-Salute San Raffaele. The principal investigator is Giovanni Landoni, MD at IRCCS San Raffaele. The trial plans to enroll 50 participants.