Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2018-12-30

Brief Summary

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The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.

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Detailed Description

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Conditions

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COPD Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Feasibility

Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback.

Group Type EXPERIMENTAL

AIR-AD

Intervention Type DEVICE

Non-significant risk medical device as decided by institutional review board

Part 2: Crossover

Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it.

Group Type EXPERIMENTAL

AIR-AD

Intervention Type DEVICE

Non-significant risk medical device as decided by institutional review board

Interventions

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AIR-AD

Non-significant risk medical device as decided by institutional review board

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1\. Moderate to severe COPD (by ATS criteria)

1. FEV1/FVC \<0.70
2. FEV1 \< 60% Predicted

Exclusion Criteria

1. Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc…)
2. Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc…)
3. Pregnancy
4. Age \<18

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No