NCT02976324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 23, 2017

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 8, 2016

Last Update Submit

October 20, 2017

Conditions

Chronic Cor Pulmonale

Outcome Measures

Primary Outcomes (1)

  • cardiopulmonary function

    six miunte walk test

    10 days

Secondary Outcomes (1)

  • MIP

    10 DAYS

Study Arms (2)

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

external diaphragmatic pacemaker groupDEVICE

9 counts per minute, with stimulate frequency 40 Hz

external diaphragmatic pacemaker group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of chronic cor pulmonale and admit to hospital

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • xiangyu zhang, doctor

    Tongji University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Intensive care medicine

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 29, 2016

Study Start

November 1, 2016

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

October 23, 2017

Record last verified: 2016-11

Locations

CN(1)