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.
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 to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O
The device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.
Città di Lecce Hospital
Lecce, Apulia, Italy
NOT_YET_RECRUITINGIRCCS San Raffaele
Milan, Italy
RECRUITINGUniversità degli studi di Verona
Verona, Italy
NOT_YET_RECRUITINGDevice easiness-to-use
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.
Time frame: Up to 2 hours
Duration of proper pressure delivery
Total time of target pressure (4 - 15 cmH2O) during 15-min test
Time frame: Up to 2 hours
Battery power consumption and duration
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.
Time frame: Up to 2 hours
Change in SpO2 level
Change in SpO2 before and during the device application
Time frame: Up to 2 hours
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