The Effect of External Diaphragmatic Pacemaker on the Pat... | NCT02976324

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

NCT02976324

Sponsor

Zhang Xiangyu

Status

Completed

Last Update Posted

Oct 23, 2017Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Chronic Cor Pulmonale

Interventions

external diaphragmatic pacemaker group

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

May 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Nov 8, 2016

First Submission Date that Met QC Criteria

Nov 24, 2016

First Posted Date

Nov 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2017

Last Update Posted Date

Oct 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
external diaphragmatic pacemaker group	Experimental	use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz	Device: external diaphragmatic pacemaker group
control group	No Intervention	No inervention, just receive conventional therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
external diaphragmatic pacemaker group	Device	9 counts per minute, with stimulate frequency 40 Hz	external diaphragmatic pacemaker group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
MIP	MAX INSPIRATORY PRESSURE	10 DAYS

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
xiangyu zhang, doctor	Tongji University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Tenth People's Hospital		Shanghai	Shanghai Municipality	200072	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011660	Pulmonary Heart Disease

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided