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A New Portable Device for Non-invasive Ventilatory Support

Study acronym: PREVENT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 6, 2026 (before its estimated May 19, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion pushed from Apr 1, 2026 to May 19, 2026
    • Study completion pushed from May 19, 2026 to Jun 19, 2026
    v7
  2. Primary completion date: Oct 1, 2025 to Apr 1, 2026
    • Study completion date: Nov 19, 2025 to May 19, 2026
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2025 to Sep 17, 2025
    • Site details revised at 3 of 3 sites
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Start date: Apr 1, 2025 to Sep 1, 2025v3
  6. Start date: Feb 1, 2025 to Apr 1, 2025v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06716502
Lead Sponsor Università Vita-Salute San Raffaele
Collaborators: Azienda Ospedaliera Universitaria Integrata Verona, Città di Lecce Hospital
Conditions
(from sponsor)		 Healthy, Respiratory Disease
Related terms Respiration Disorders, Respiratory Insufficiency
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov