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

Università Vita-Salute San Raffaele

Status: Enrolling

Conditions: Healthy; Respiratory Disease

Treatments: Device: Portable CPAP efficacy; Device: Portable CPAP usability assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06716502

PNRR-POC-2022-12376704

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Healthy elderly individuals

Experimental group

Description:

The performance and easiness to use of the device will be evaluated in patients' self-experience conditions, with elderly participants self-applying the device.

Treatment:

Device: Portable CPAP usability assessment

Patients with mild oxygenation impairment

Experimental group

Description:

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

Treatment:

Device: Portable CPAP efficacy