A New Portable Device for Non-invasive Ventilatory Support
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversità Vita-Salute San Raffaele
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Hospitalized adult patient
SpO2 of 90-93% in room air
Facial burns/trauma/recent facial or upper airway surgery
Vomiting
Trial design
Design model
Single group
Treatments tested in this trial
Portable CPAP efficacy
DeviceThe device will be tested in providing a PEEP comprised between 4-7,5 cmH2O
Portable CPAP usability assessment
DeviceThe device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Healthy elderly individualsExperimental treatment 1 intervention
Group B: Patients with mild oxygenation impairmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device 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 hours2
Duration of proper pressure delivery
Total time of target pressure (4 - 15 cmH2O) during 15-min test
Time frame
Up to 2 hours3
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 hours4
Change in SpO2 level
Change in SpO2 before and during the device application
Time frame
Up to 2 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Università Vita-Salute San Raffaele
Lead sponsor
IRCCS San Raffaele
Sponsor institution
Azienda Ospedaliera Universitaria Integrata Verona
Collaborator
Città di Lecce Hospital
Collaborator
Source ClinicalTrials.gov