The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale

Zhang Xiangyu

Status: Completed

Conditions: Chronic Cor Pulmonale

Treatments: Device: external diaphragmatic pacemaker group

Study type: Interventional

Funder types: Other

Identifiers

NCT02976324

EDPCCP2016

Details and patient eligibility

About

This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.

Full description

Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,NT-proBNP,PaO2 and PaCO2.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of chronic cor pulmonale and admit to hospital

Exclusion criteria

• pneumothorax or mediastinal emphysema
• active tuberculosis
• install a cardiac pacemaker
• acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents.
• pregnancies
• end-stage patients (expected survival time less than 6 months)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

external diaphragmatic pacemaker group

Experimental group

Description:

use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz

Treatment:

Device: external diaphragmatic pacemaker group

control group

No Intervention group

Description:

No inervention, just receive conventional therapy