What is this study trying to find out about acute respiratory failure?

This study is evaluating a new portable CPAP device designed to support breathing in acute respiratory failure outside of hospitals. Researchers want to see how well the device works and how easy it is for people, including elderly individuals, to use it in real situations. The study is led by Università Vita-Salute San Raffaele.

Who may be eligible for this respiratory disease clinical trial?

Adults aged 65 years or older who are either healthy and able to self-apply the device or hospitalized with mild oxygenation impairment may be eligible. Participants should not have recent facial trauma or airway surgery and must be able to give informed consent. Please review eligibility criteria for more details.

Is there any cost to participate in this respiratory disease clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive the device and monitoring without charge during the study.

Actively Recruiting

Phase Not Applicable

Age: 65Years +

All Genders

Healthy Volunteers

ID06716502

Evaluation of a New Portable CPAP Device for Non-invasive Respiratory Support in Elderly and Respiratory-Impaired Patients

Led by Università Vita-Salute San Raffaele · Updated on 2026-05-06

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Acute respiratory failure is a serious medical emergency that can quickly lead to death without prompt treatment. Researchers are evaluating a new portable device designed to provide Continuous Positive Airway Pressure CPAP support outside of hospital settings. This device aims to be easy to use by non-medical individuals and to improve outcomes for patients experiencing respiratory failure. The study will test the devices effectiveness and usability in two groups healthy elderly adults who will self-apply the device, and hospitalized patients with mild oxygenation impairment. The device is designed to deliver positive end-expiratory pressure PEEP between 4 and 7.5 cmH2O, and its performance will be assessed in real-world clinical settings across three hospitals. Participants will be monitored for up to 2 hours during device use, with assessments including how easy the device is to use, duration of proper pressure delivery, battery consumption and duration, and changes in blood oxygen levels SpO2. The study will collect data to support the devices future use as a first-aid tool for respiratory failure outside hospitals. The total study duration and follow-up details are not specified.

CONDITIONS

Brief Title

A New Portable Device for Non-invasive Ventilatory Support

Who Can Participate

Age: 65Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Age 65 years or older
Clinically stable: non-hospitalized and not in acute illness (Arm 1)
No professional medical knowledge or experience as a healthcare provider (Arm 1)
Ability to give informed consent as required by the ethical committee (Arm 1)
Hospitalized adult patient (Arm 2)
Blood oxygen saturation (SpO2) between 90% and 93% on room air (Arm 2)

You will not qualify if you...

Facial burns, trauma, or recent surgery to face or upper airway (Arm 2)
Vomiting (Arm 2)
Fixed upper airway obstruction (Arm 2)
Undrained pneumothorax (Arm 2)
Recent upper gastrointestinal surgery (Arm 2)
Inability to protect the airway (Arm 2)
Bowel obstruction (Arm 2)
Patient refusal (Arm 2)

Research Team

Giovanni Landoni, MD

Rosalba Lembo

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here