Prognostic Value Cardiac Dysfunction Assessed by Bedside Echocardiography in Critically Ill COPD Patients Requiring Mechanical Ventilation

August 31, 2015 updated by: Zhongheng Zhang, Jinhua Central Hospital
Chronic obstructive lung disease (COPD) is a major cause of morbidity and mortality, and is a major reason for ICU admission. Cardiac function is often impaired in this disease but its association with clinical outcome has not been fully established. The study aims to investigate the association between cardiac dysfunction and clinclial outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study conducted in a 47-bed mixed ICU of tertiary academic teaching hospital. The study will be performed between January 2014 to December 2015. All patients meeting the diagnostic criteria of AECOPD and admitted to ICU are potentially eligible for the present study. Relevant demographics and laboratory measurements are obtained. Transthoracic echocardiography (TTE) is performed immediately after ICU admission by experienced intensivists. Cox proportional hazard regression model is fitted by using stepwise forward selection and backward elimination technique. If linear assumption is not satisfied, the linear spline function will be used.

Study Type

Observational

Enrollment (Actual)

53

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
    • Zhejiang
      • Jinhua, Zhejiang, China, 321000
        • Jinhua Municipal Central 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients meeting the diagnostic criteria of AECOPD and admitted to ICU are potentially eligible for the present study. The diagnosis of AECOPD is based on that defined in Global Initiative for Chronic Obstructive Pulmonary Disease. AECOPD is defined using definitive criteria with at least two of the following major symptoms: increased dyspnea, increased sputum purulence, increased sputum volume; or one major and one minor symptom: nasal discharge/congestion, wheeze, sore throat and cough for at least two consecutive days.

Description

Inclusion Criteria:

  • COPD patients experiencing episode of exacerbation and require mechanical ventilation were admitted to ICU

Exclusion Criteria:

  • COPD patients admitted to ICU due to other reasons (major surgery, ischemic heart disease, and renal failure)
  • moribund and expected to die within 48 hours
  • with Do-Not-Resuscitation order

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
echocardiography examination
Device: echocardiography examination
patients underwent echocardiography examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days after ICU admission
28 days after ICU admission; if a patient leave ICU before 28-days, it is considered as censored.
28 days after ICU admission

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of mechanical ventilation
Time Frame: from ICU admission to extubation, an expected average of 8 days
from ICU admission to extubation, an expected average of 8 days

Collaborators and Investigators

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

Sponsor

Jinhua Central Hospital

Investigators

  • Study Chair: Chen Kun, MB, Jinhua Municipal Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 23, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • echo_COPD
  • echo and COPD (Registry Identifier: echo and COPD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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