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

Mechanical Ventilation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099279
• Other study ID #: echo_COPD
• Secondary ID: echo and COPD
• Status: Completed
• Phase: N/A
• First received: March 23, 2014
• Last updated: August 31, 2015
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2014
• Source: Jinhua Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD Patients
• Mechanical Ventilation

Intervention

Device:
• echocardiography examination
patients underwent echocardiography examination

Locations

Country	Name	City	State
China	Jinhua municipal central hospital	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jinhua Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	28 days after ICU admission; if a patient leave ICU before 28-days, it is considered as censored.	28 days after ICU admission	No
Secondary	duration of mechanical ventilation		from ICU admission to extubation, an expected average of 8 days	No