COPD PatientsNCT02099279
Prognostic Value Cardiac Dysfunction Assessed by Bedside Echocardiography in Critically Ill COPD Patients Requiring Mechanical Ventilation
An observational study of COPD Patients and Mechanical Ventilation, run by Jinhua Central Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Patients, Mechanical Ventilation
- What is being tested?
- echocardiography examination
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- COPD patients experiencing episode of exacerbation and require mechanical ventilation were admitted to ICU
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- COPD Patients, Mechanical Ventilation
- Being tested
- echocardiography examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography examinationDevice
patients underwent echocardiography examination
| Study group | Role | What they receive |
|---|---|---|
| echocardiography examination | Not described Receives: Device: echocardiography examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
28 days after ICU admission; if a patient leave ICU before 28-days, it is considered as censored.
Measured: 28 days after ICU admission
Secondary outcomes (1)
duration of mechanical ventilation
Measured: from ICU admission to extubation, an expected average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinhua Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongheng Zhang, Jinhua Central Hospital
- Investigators
- Chen Kun, MB, Study chair, Jinhua Municipal Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099279
- Sponsor's protocol ID
- echo_COPD
- Other IDs
- echo and COPD
- Status last verified
- Mar 2014
- First submitted
- 23 Mar 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25256186
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value Cardiac Dysfunction Assessed by Bedside Echocardiography in Critically Ill COPD Patients Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02099279
- Acronym / sponsor ID
- echo_COPD
- Conditions
- COPD Patients, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Jinhua Central HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| echocardiography examination | – | Device: echocardiography examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- COPD patients experiencing episode of exacerbation and require mechanical ventilation were admitted to ICU
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiography examinationpatients underwent echocardiography examination | Device | echocardiography examination |
Primary outcome
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.
1 secondary outcome
duration of mechanical ventilation
Time frame: from ICU admission to extubation, an expected average of 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
- Derived from this study: PubMed 25256186Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Kun, MB study chair
Jinhua Municipal Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Patients and Mechanical Ventilation, run by Jinhua Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.