Actively Recruiting
A New Portable Device for Non-invasive Ventilatory Support
Led by Università Vita-Salute San Raffaele · Updated on 2026-05-06
50
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
Università Vita-Salute San Raffaele
Lead Sponsor
A
Azienda Ospedaliera Universitaria Integrata Verona
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A New Portable Device for Non-invasive Ventilatory Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Clinically stable: not hospitalized and not in acute illness
- No professional medical knowledge or experience as a healthcare provider
- Ability to provide informed consent as required by the ethical committee
- Hospitalized adult patient with oxygen saturation (SpO2) between 90-93% on room air
You will not qualify if you...
- Facial burns, trauma, or 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Città di Lecce Hospital
Lecce, Apulia, Italy
Not Yet Recruiting
2
IRCCS San Raffaele
Milan, Italy, 20132
Actively Recruiting
3
Università degli studi di Verona
Verona, Italy
Not Yet Recruiting
Research Team
G
Giovanni Landoni, MD
CONTACT
R
Rosalba Lembo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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