Clinical Evaluation of COPD Butler in Patient Home Management

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 has been suggested to be essential for delaying diseases progress, reducing acute exacerbation events and improving patient quality of life. Non-invasive ventilation (NIV) is a widely used treatment in COPD patients. There were studies shown that NIV could improve ventilation, blood gases etc., and several clinical trials have shown improvements in survival, exercise capacity, quality of life and so on. Compliance to NIV and optimal parameter setting are important factors that will affect the effect of the use of NIV, thus NIV usage monitoring might also be a crucial element in the health management of COPD patients. Many studies have been designed to study the effect of tele-monitoring program on the management of COPD patients. However, almost none of these studies were designed for specific population, and little is known about the effect of such program on the management of patients with NIV treatment.

Conditions

• COPD
• Hypercapnic Respiratory Failure

Interventions

DEVICE

NIV with the integrated tele-monitoring management program

Noninvasive positive pressure ventilation with the integrated tele-monitoring management will provide regular health report, and once an alert is generated due to the abnormality in NIV usage or vital sign data etc., physicians will take action accordingly.

Sponsors & Collaborators

• Guangdong Second Provincial General Hospital

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• Huizhou Municipal Central Hospital

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• Clifford Hospital, Guangzhou, China

  collaborator OTHER

• Shenzhen Sixth People's Hospital

  collaborator OTHER

• Subei People's Hospital of Jiangsu Province

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Principal Investigators

• Rongchang Chen, MD · Guangzhou Institute of Respiratory Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• China

Study Locations