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

NCT ID: NCT02976324

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Chronic Cor Pulmonale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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external diaphragmatic pacemaker group

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

Group Type EXPERIMENTAL

external diaphragmatic pacemaker group

Intervention Type DEVICE

9 counts per minute, with stimulate frequency 40 Hz

control group

No inervention, just receive conventional therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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external diaphragmatic pacemaker group

9 counts per minute, with stimulate frequency 40 Hz

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhang Xiangyu

OTHER

Sponsor Role lead

Responsible Party

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Zhang Xiangyu

Director of Intensive care medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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xiangyu zhang, doctor

Role: PRINCIPAL_INVESTIGATOR

Tongji University

Locations

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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EDPCCP2016

Identifier Type: -

Identifier Source: org_study_id