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A New Portable Device for Non-invasive Ventilatory Support

NCT06716502 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-06

No results posted yet for this 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.

Conditions

  • Healthy
  • Respiratory Disease

Interventions

DEVICE

Portable CPAP efficacy

The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O

DEVICE

Portable 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 & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    collaborator OTHER

  • Città di Lecce Hospital

    collaborator UNKNOWN

  • Università Vita-Salute San Raffaele

    lead OTHER

Principal Investigators

  • Giovanni Landoni, MD · IRCCS San Raffaele

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-17
Primary Completion
2026-05-19
Completion
2026-06-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716502 on ClinicalTrials.gov