Back to resultsThe Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
Primary Purpose
Chronic Cor Pulmonale
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
external diaphragmatic pacemaker group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Cor Pulmonale
Eligibility Criteria
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)
Sites / Locations
- Shanghai Tenth People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
external diaphragmatic pacemaker group
control group
Arm Description
use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz
No inervention, just receive conventional therapy
Outcomes
Primary Outcome Measures
cardiopulmonary function
six miunte walk test
Secondary Outcome Measures
MIP
MAX INSPIRATORY PRESSURE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02976324
Brief Title
The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
Official Title
The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhang Xiangyu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cor Pulmonale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
external diaphragmatic pacemaker group
Arm Type
Experimental
Arm Description
use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz
Arm Title
control group
Arm Type
No Intervention
Arm Description
No inervention, just receive conventional therapy
Intervention Type
Device
Intervention Name(s)
external diaphragmatic pacemaker group
Intervention Description
9 counts per minute, with stimulate frequency 40 Hz
Primary Outcome Measure Information:
Title
cardiopulmonary function
Description
six miunte walk test
Time Frame
10 days
Secondary Outcome Measure Information:
Title
MIP
Description
MAX INSPIRATORY PRESSURE
Time Frame
10 DAYS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiangyu zhang, doctor
Organizational Affiliation
Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
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