A New Portable Device for Non-invasive Ventilatory Support

Last updated: May 5, 2026
Sponsor: Università Vita-Salute San Raffaele
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Lung Disease

Treatment

Portable CPAP efficacy

Portable CPAP usability assessment

Clinical Study ID

NCT06716502
PNRR-POC-2022-12376704
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

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

Exclusion

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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Portable CPAP efficacy
Phase:
Study Start date:
September 17, 2025
Estimated Completion Date:
June 19, 2026

Study 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.

Connect with a study center

  • Città di Lecce Hospital

    Lecce, Apulia
    Italy

    Site Not Available

  • Città di Lecce Hospital

    Lecce 3174953, Apulia 3169778
    Italy

    Site Not Available

  • IRCCS San Raffaele

    Milan, 20132
    Italy

    Active - Recruiting

  • IRCCS San Raffaele

    Milan 3173435, 20132
    Italy

    Site Not Available

  • Università degli studi di Verona

    Verona,
    Italy

    Site Not Available

  • Università degli studi di Verona

    Verona 3164527,
    Italy

    Site Not Available

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