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

Chronic Cor Pulmonale Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976324
• Other study ID #: EDPCCP2016
• Status: Completed
• Phase: N/A
• First received: November 8, 2016
• Last updated: October 20, 2017
• Start date: November 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2016
• Source: Tongji University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Cor Pulmonale
• Pulmonary Heart Disease

Intervention

Device:
• external diaphragmatic pacemaker group
9 counts per minute, with stimulate frequency 40 Hz

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Xiangyu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiopulmonary function	six miunte walk test	10 days
Secondary	MIP	MAX INSPIRATORY PRESSURE	10 DAYS