A New Portable Device for Non-invasive Ventilatory Support

Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · Nov 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new portable device designed to help people with breathing difficulties, specifically in situations where they are not in a hospital. The device provides a type of treatment called Continuous Positive Airway Pressure (CPAP), which can improve breathing and is especially important during emergencies like acute respiratory failure. The goal of the trial is to see how well this device works and how easy it is for everyday people to use, even if they don’t have medical training.

To participate in the trial, there are specific eligibility criteria. For one group, participants must be at least 65 years old, stable (not currently sick or hospitalized), and have no medical training. Another group includes hospitalized adults with certain breathing issues (specifically, blood oxygen levels between 90-93%). Throughout the trial, participants will be assessed on their experience using the device. This trial is not yet recruiting participants, but if you meet the criteria and are interested, it could be an important step in improving emergency care for breathing problems outside of hospitals.

Gender

ALL

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