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A New Portable Device for Non-invasive Ventilatory Support

RecruitingNAAges 65 Years - anyAllUniversità Vita-Salute San Raffaele
NCT06716502 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Portable CPAP efficacy
  • Portable CPAP usability assessment
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Where

3 sites
Città di Lecce Hospital
Lecce, Italy
IRCCS San Raffaele
Milan, Italy
Università degli studi di Verona
Verona, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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