Status:
RECRUITING
A New Portable Device for Non-invasive Ventilatory Support
Lead Sponsor:
Università Vita-Salute San Raffaele
Collaborating Sponsors:
Azienda Ospedaliera Universitaria Integrata Verona
Città di Lecce Hospital
Conditions:
Healthy
Respiratory Disease
Eligibility:
All Genders
65+ years
Phase:
NA
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 CPA...
Detailed Description
The efficacy and usability of a new portable CPAP device will be assessed in different clinical settings. The study will take place in three hospitals in Italy, with the objective of collecting data t...
Eligibility Criteria
Arm 1
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Key Trial Info
Start Date :
September 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 19 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06716502
Start Date
September 17 2025
End Date
May 19 2026
Last Update
March 20 2026
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Città di Lecce Hospital
Lecce, Apulia, Italy
2
IRCCS San Raffaele
Milan, Italy, 20132
3
Università degli studi di Verona
Verona, Italy