Actively Recruiting
A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
Led by Università Vita-Salute San Raffaele · Updated on 2026-05-06
50
Participants Needed
3
Research Sites
4 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 serious medical emergency that can quickly lead to death without prompt treatment. Researchers are evaluating a new portable device designed to provide Continuous Positive Airway Pressure (CPAP) support outside of hospital settings. This device aims to be easy to use by non-medical individuals and to improve outcomes for patients experiencing respiratory failure. The study will test the device's effectiveness and usability in two groups: healthy elderly adults who will self-apply the device, and hospitalized patients with mild oxygenation impairment. The device is designed to deliver positive end-expiratory pressure (PEEP) between 4 and 7.5 cmH2O, and its performance will be assessed in real-world clinical settings across three hospitals. Participants will be monitored for up to 2 hours during device use, with assessments including how easy the device is to use, duration of proper pressure delivery, battery consumption and duration, and changes in blood oxygen levels (SpO2). The study will collect data to support the device's future use as a first-aid tool for respiratory failure outside hospitals. The total study duration and follow-up details are not specified.
CONDITIONS
Brief 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: non-hospitalized and not in acute illness (Arm 1)
- No professional medical knowledge or experience as a healthcare provider (Arm 1)
- Ability to give informed consent as required by the ethical committee (Arm 1)
- Hospitalized adult patient (Arm 2)
- Blood oxygen saturation (SpO2) between 90% and 93% on room air (Arm 2)
You will not qualify if you...
- Facial burns, trauma, or recent surgery to face or upper airway (Arm 2)
- Vomiting (Arm 2)
- Fixed upper airway obstruction (Arm 2)
- Undrained pneumothorax (Arm 2)
- Recent upper gastrointestinal surgery (Arm 2)
- Inability to protect the airway (Arm 2)
- Bowel obstruction (Arm 2)
- Patient refusal (Arm 2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 hours
Participants use the portable CPAP device to assess its efficacy and usability in providing non-invasive ventilatory support.
1 to 2 visits depending on participant group
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
R
Rosalba Lembo
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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