A New Portable Device for Non-invasive Ventilatory Support

NCT06716502 | Recruiting DMC

• 1 other identifier: PNRR-POC-2022-12376704
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

CPAP; NIV; Respiratory failure

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Healthy elderly individuals

EXPERIMENTAL

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

Patients with mild oxygenation impairment

EXPERIMENTAL

The efficacy of the device will be assessed in patients with mild oxygenation impairment.

Device: Portable CPAP efficacy

Interventions

Portable CPAP efficacy DEVICE

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

Patients with mild oxygenation impairment

Portable CPAP usability assessment DEVICE

The device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.

Healthy elderly individuals

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years
• Clinically stable: non-hospitalized and not in acute illness
• no professional medical knowledge: no experience as a health care provider
• Ability to express informed consent as requested by the ethical committee

You may not qualify if:

• Arm 2
• Hospitalized adult patient
• SpO2 of 90-93% in room air
• Arm 2
• Facial burns/trauma/recent facial or upper airway surgery
• Vomiting
• Fixed upper airway obstruction
• Undrained pneumothorax
• Recent upper gastrointestinal surgery
• Inability to protect the airway
• Bowel obstruction
• Patient refusal

Sponsors & Collaborators

• Città di Lecce Hospital: collaborator
• Università Vita-Salute San Raffaele: lead
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator

Study Sites (3)

Città di Lecce Hospital

Lecce, Apulia, Italy

NOT YET RECRUITING

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Università degli studi di Verona

Verona, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Giovanni Landoni, MD

  IRCCS San Raffaele

  STUDY CHAIR

Central Study Contacts

Giovanni Landoni, MD

CONTACT

+39 022643; landoni.giovanni@hsr.it

Rosalba Lembo

CONTACT

+39 022643; lembo.rosalba@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Research Center for Intensive Care and Anesthesiology of San Raffaele Scientific Institute

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: December 4, 2024
• Study Start: September 17, 2025
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)