## Protocol Section
### Identification Module
**NCT ID:** NCT02099279

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

#### Organization Study ID Info
**ID:** echo_COPD
#### Organization
**Class:** OTHER
**Full Name:** Jinhua Central Hospital
#### Secondary ID Infos
**Domain:** echo and COPD
**ID:** echo and COPD
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2015-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-09-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-08-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-01

**Type:** ACTUAL

#### Start Date
**Date:** 2014-01

**Status Verified Date:** 2014-03

#### Study First Post Date
**Date:** 2014-03-28
**Type:** ESTIMATED
**Study First Submit Date:** 2014-03-23
**Study First Submit QC Date:** 2014-03-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Jinhua Central Hospital

#### Responsible Party

**Investigator Affiliation:** Jinhua Central Hospital

**Investigator Full Name:** Zhongheng Zhang

**Investigator Title:** intensivist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- COPD Patients

- Mechanical Ventilation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 53

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: echocardiography examination

**Label:** echocardiography examination

### Interventions

#### Intervention 1

**Arm Group Labels:**

- echocardiography examination

**Description:** patients underwent echocardiography examination

**Name:** echocardiography examination

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 28 days after ICU admission; if a patient leave ICU before 28-days, it is considered as censored.

**Measure:** 28-day mortality

**Time Frame:** 28 days after ICU admission

#### Secondary Outcomes

**Measure:** duration of mechanical ventilation

**Time Frame:** from ICU admission to extubation, an expected average of 8 days

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jinhua

**Country:** China

**Facility:** Jinhua municipal central hospital

**State:** Zhejiang

**Zip:** 321000

#### Overall Officials

**Official 1:**

**Affiliation:** Jinhua Municipal Central Hospital

**Name:** Chen Kun, MB

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Zhang Z, Chen L, Chen K, Ni H. The prognostic value of cardiac dysfunction assessed by bedside echocardiography in critically ill patients with COPD requiring mechanical ventilation: a study protocol. BMJ Open. 2014 Sep 25;4(9):e005359. doi: 10.1136/bmjopen-2014-005359.

**PMID:** 25256186

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
