Pilot, Single Center, Feasibility Study of Cuirass Biphasic Ventilator in Chronic Obstructive Pulmonary Disease Patients

Brief description of study

The research study is being conducted to learn about the work of breathing support that an external breathing support device can provide compared to a person’s baseline ability. The research study is sponsored by RightAir Inc, the makers of the device being investigated, the AIR-AD cuirass ventilator. This study is a pilot study to explore the benefits of the AIR-AD device (which is currently unapproved for medical use) for patients with COPD in improving their exertional capacity. Exertional capacity is a patient’s ability to ambulate. This will be measured by a 6-minute walk test. They are interested in demonstrating the benefit of this device for patients with COPD so that it can be offered for patients in the future. They are also interested in seeing whether the device may offer a benefit over what is currently available, an older style cuirass ventilator called the PegasoTM.

Detailed description of study

If you agree to join the study, you will be asked to complete the following research procedures: Participants for this study will perform a 6-minute walk test, with and without one of the support devices during a study visit. There are three parts of the study and participants can participate in one, two or all three parts if they so choose.

Up to 60 volunteer COPD patients total could participate in this study, and all research will be performed at Penn Medicine. For each part of the study that a participant is willing to participate there will be one (1) visit that will take approximately 2-3 hours. Part 1A of the study will recruit 10 patients to look at whether the currently available commercial ventilator, the PegasoTM, helps patients with COPD walk further on a 6- minute walk test Part 1B of the study will recruit 10 patients to look at whether the AIR-AD device will help patients with COPD walk further on a 6-minute walk test. There will also be more in-depth questions from the sponsors on how to improve the user experience and how to improve the fit of the device. Part 2 will recruit up to 40 patients to look at whether the AIR-AD device will help patients with COPD walk further on a 6-minute walk test. This part will not have the more in-depth user-experience questions from part 1B. For each part of the study that you are willing to participate in, there will be one (1) visit that will take approximately 2-3 hours. Your participation in this study will help gather information that may be beneficial to other patients in the future. It is not anticipated that you will receive any medical benefits from being in this study. The most common risks of participation are temporary shortness of breath during the 6-minute walk tests. There are no other known risks. Please note that there are other factors to consider before agreeing to participate such as additional procedures, use of your personal information, costs, and other possible risks not discussed here. If you are interested in participating, a member of the study team will review the full information with you. You are free to decline or stop participation at any time during or after the initial consenting process. If you choose not to participate in the study, there will be no impact to your care at Penn Medicine.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
COPD
Age: Between 21 Years - 79 Years
Gender: All

Inclusion Criteria

Severe COPD (by ATS criteria)
Post bronchodilator FEV1/FVC <0.70
FEV1 < 50% Predicted
Modified Medical Research Council (mMRC) Dyspnea scale >=2
On file Pulmonary Function Testing results within the last year

Exclusion Criteria

Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, COPD exacerbation, etc)
Lung pathology not explained by chronic COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc)
Females of childbearing potential (FOCBP) defined as pre-menopausal, < 12 months of amenorrhea post-menopause or no history of surgical sterilization
Patients shorter than 5 feet tall or taller than 6 feet

Patients with a body mass index (BMI) greater than 30

Patients that do not fit into existing cuirass sizes or unable to obtain a good seal

Updated on 09 Mar 2024. Study ID: 852896

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