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

October 20, 2017 updated by: Zhang Xiangyu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: external diaphragmatic pacemaker group
use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz
Device: external diaphragmatic pacemaker group
9 counts per minute, with stimulate frequency 40 Hz
NO_INTERVENTION: control group
No inervention, just receive conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiopulmonary function
Time Frame: 10 days
six miunte walk test
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MIP
Time Frame: 10 DAYS
MAX INSPIRATORY PRESSURE
10 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhang Xiangyu

Investigators

  • Principal Investigator: xiangyu zhang, doctor, Tongji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 24, 2016

First Posted (ESTIMATE)

November 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2017

Last Update Submitted That Met QC Criteria

October 20, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDPCCP2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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