A New Portable Device for Non-invasive Ventilatory Support

Not Applicable

Not yet recruiting

• Conditions: Healthy; Respiratory Disease

• Registration Number: NCT06716502
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

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 Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-28
• Study First Posted: 2024-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Study Start: 2025-04-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Device easiness-to-use	Up to 2 hours	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.
Duration of proper pressure delivery	Up to 2 hours	Total time of target pressure (4 - 15 cmH2O) during 15-min test
Battery power consumption and duration	Up to 2 hours	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.
Change in SpO2 level	Up to 2 hours	Change in SpO2 before and during the device application

Trial Locations

Locations (3)

Città di Lecce Hospital; 🇮🇹 Lecce, Puglia, Italy

IRCCS San Raffaele; 🇮🇹 Milan, Italy

Università degli studi di Verona; 🇮🇹 Verona, Italy