A New Portable Device for Non-invasive Ventilatory Support (PREVENT)

A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Respiratory Disease
• Intervention / Treatment: Device: Portable CPAP usability assessment; Device: Portable CPAP efficacy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanni Landoni, MD; Phone Number: 6151 +39 022643; Email: landoni.giovanni@hsr.it
• Study Contact Backup: Name: Rosalba Lembo; Phone Number: 6151 +39 022643; Email: lembo.rosalba@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS San Raffaele
    • Contact: Giovanni Landoni, MD; Email: landoni.giovanni@hsr.it
  • Verona, Italy
    • Not yet recruiting
    • Università degli studi di Verona
    • Contact: Katia Donadello, MD
  • Apulia
    • Lecce, Apulia, Italy
      • Not yet recruiting
      • Città di Lecce Hospital
      • Contact: Giuseppe Santarpino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy elderly individuals; The performance and easiness to use of the device will be evaluated in patients' self-experience conditions, with elderly participants self-applying the device.	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.
Experimental: Patients with mild oxygenation impairment; The efficacy of the device will be assessed in patients with mild oxygenation impairment.	Device: Portable CPAP efficacy; The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device easiness-to-use	Volunteers in self-experience tests will be asked to assign a score depending on the easiness-to-use of the device and comfort during the device operation. A semantic differential scale will be used between "hard to use" (corresponding to the score 1) and "easy to use" (corresponding to the score 5). The best result is represented by a higher score, with 5 being the highest and 1 the lowest.	Up to 2 hours
Duration of proper pressure delivery	Total time of target pressure (4 - 15 cmH2O) during 15-min test	Up to 2 hours
Battery power consumption and duration	We will set 15 minutes of continuous device operation as an efficacy threshold and will assess the battery status at the end of each experiment.	Up to 2 hours
Change in SpO2 level	Change in SpO2 before and during the device application	Up to 2 hours

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele
• Collaborators: Azienda Ospedaliera Universitaria Integrata Verona; Città di Lecce Hospital
• Investigators: Study Chair: Giovanni Landoni, MD, IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): June 19, 2026

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CPAP; NIV; Respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiratory Insufficiency; Respiration Disorders
• Other Study ID Numbers: PNRR-POC-2022-12376704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No