Portable CPAP efficacy: The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O
Portable CPAP usability assessment: The device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.
Study 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
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Device easiness-to-use — Up to 2 hours Volunteers in self-experience tests will be asked to assign a score depending on the easiness-to-use of the device and comfort during the device operation.
A semantic differential scale will be used between "hard to use" (corresponding to the score 1) and "easy to use" (corresponding to the score 5). The best result is represented by a higher score, with 5 being the highest and 1 the lowest.
Duration of proper pressure delivery — Up to 2 hours Total time of target pressure (4 - 15 cmH2O) during 15-min test
Battery power consumption and duration — Up to 2 hours We will set 15 minutes of continuous device operation as an efficacy threshold and will assess the battery status at the end of each experiment.
Change in SpO2 level — Up to 2 hours Change in SpO2 before and during the device application
Trial sites (3)
Facility
City
Region
Status
Città di Lecce Hospital
Lecce
Apulia
Not Yet Recruiting
IRCCS San Raffaele
Milan
Italy
Recruiting
Università degli studi di Verona
Verona
Italy
Not Yet Recruiting
More Università Vita-Salute San Raffaele trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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