A New Portable Device for Non-invasive Ventilatory Support
Trial Parameters
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.
Eligibility 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 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