Status:
UNKNOWN
Clinical Evaluation of COPD Butler in Patient Home Management
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
Guangdong Second Provincial General Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions:
COPD
Hypercapnic Respiratory Failure
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is a worldwide common disease with high morbidity and mortality and leads to heavy social and economic burden. Health management of stable COPD patients ha...
Detailed Description
The COPD home management program consists of 3 Philips devices (NIV BiPAP ST, Oximeter and Blood Pressure Meter), a patient mobile APP which is developed for self-management at home and a professional...
Eligibility Criteria
Inclusion
- Age 40-80, males and females
- Stage III and IV COPD
- Daytime hypercapnia (PaCO2 ≥ 50 mmHg) at rest without ventilatory support
- Possess home oxygen concentrator
- Participants/Caregivers have access to and capable of using smartphone and internet
- Willing to participate in the study
- Able to provide informed consent
Exclusion
- Subjects with NIV as routine therapy prior to the study
- Subjects with abnormalities of the lung or thorax other than COPD
- Subjects with obstructive sleep apnea, COPD with obstructive sleep apnea overlap syndrome, severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities
- Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
- Subjects who participated in another trial within 30 days prior to the planned start of study
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03471091
Start Date
April 1 2018
End Date
December 31 2022
Last Update
March 2 2021
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong, China, 510120