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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02976324
Enrollment
50
Registered
2016-11-29
Start date
2016-11-30
Completion date
2017-08-31
Last updated
2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Cor Pulmonale

Brief 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.

Detailed 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.

Interventions

DEVICEexternal diaphragmatic pacemaker group

9 counts per minute, with stimulate frequency 40 Hz

Sponsors

Zhang Xiangyu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
cardiopulmonary function10 dayssix miunte walk test

Secondary

MeasureTime frameDescription
MIP10 DAYSMAX INSPIRATORY PRESSURE

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026