A New Portable Device for Non-invasive Ventilatory Support

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-17

Study Completion Date

2025-11-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Respiratory Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Portable CPAP usability assessment

Intervention Type 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.

Patients with mild oxygenation impairment

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

Group Type EXPERIMENTAL

Portable CPAP efficacy

Intervention Type DEVICE

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

Interventions

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Portable CPAP efficacy

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

1. Hospitalized adult patient
2. SpO2 of 90-93% in room air

Arm 2

Exclusion Criteria

Arm 2

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes