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
Qualifiers
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
Treatments tested in this trial
- Portable CPAP efficacy
- Portable CPAP usability assessment
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
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