Healthy, Respiratory Disease
Conditions
Keywords
CPAP, NIV, Respiratory failure
Brief 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.
Detailed description
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.
Interventions
DEVICEPortable CPAP efficacy
The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O
DEVICEPortable 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.
Sponsors
Università Vita-Salute San Raffaele
Azienda Ospedaliera Universitaria Integrata Verona
Città di Lecce Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
CONTACTGiovanni Landoni, MD
CONTACTRosalba Lembo
STUDY_CHAIRGiovanni Landoni, MD
IRCCS San Raffaele
Outcome results
None listed