Bilateral Pleural EffusionTTENCT02548221
Impact of Large-Volume Pleural Effusions on Heart Function
An observational study of Bilateral Pleural Effusion, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly understood. Improvement of the heart and lung function may contribute to the dyspnea relief. But there is no data support this phenomenon. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Bilateral Pleural Effusion
- What is being tested?
- transthoracic echocardiogram
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Dec 2016
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients with unilateral or bilateral pleural effusion, with at least 500ml amount of effusion are enrolled in this study. Study population include malignant pleural effusion, tuberculosis pleural effusion, parapneumonic effusion, and a variety of causes for transudative pleural effusion.
Who may be able to join
- the estimated amount of effusion is above 500 ml;
- Drainage was not performed within 1 month before admission;
- assigned informed consent.
Who cannot join
- physical weakness which is difficult to withstand the thoracentesis;
- the happening of serious pleural reaction or reexpansion pulmonary edema on previous thoracentesis;
- allergy to the anesthetic;
- coagulation dysfunction, severe bleeding tendency;
- serious mental illness who do not cooperate;
- suspected with pleural hydatid disease;
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- skin infection around supine positioning;
- severe heart function insufficiency who cannot lay on the back;
- for a variety of reasons that cannot accept regular follow-up;
- refused to sign the informed consent;
- other conditions that is not suitable for the test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020
zheng wang, Ph.D, +86-13810450600, azheng178@163.com
huanzhong shi, Ph.D, +86-13911791398, shihuanzhong@sina.com
About this study
Official title: The Assessment of Heart Function Using Transthoracic Echocardiogram (TTE) Following Thoracentesis on Large-volume Pleural Effusions
The physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly understood. Improvement of the heart and lung function may contribute to the dyspnea relief. But there is no data support this phenomenon. Transthoracic echocardiogram (TTE) is a non-invasive viewing of the heart, which can quickly assess the heart function through real-time images. The investigators performed thoracentesis on patients with large-volume pleural effusions, and utilized TTE to access the change of heart and lung function before and after this medical procedure.
Read the detailed description
Patients with large pleural effusions often experience dramatic and immediate relief from dyspnea after therapeutic thoracentesis. Although this is a well-recognized phenomenon, the physiologic basis for such relief remains poorly understood. Primary physiologic basis for the relief in dyspnea after thoracentesis may include the improvement of the heart and lung function. In some cases the improvement in breathlessness cannot be attributed to the improvement of gas exchange, due to the atelectatic lung(not fully expansion of the lung). Transthoracic echocardiogram (TTE) is a non-invasive, real-time viewing of the internal parts of the heart using ultrasound, which can get highly accurate and quick assessment of the various heart images, though which doctors can quickly assess a patient's heart valves and degree of heart muscle contraction.
- Conditions
- Bilateral Pleural Effusion
- Being tested
- transthoracic echocardiogram
- Keywords
- Thoracentesis, Pleural Effusions, Transthoracic echocardiogram, Lung volume measurements
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiogramDevice
Thoracentesis was performed on patients with large-volume pleural effusions, and TTE was utilized to access the change of heart and lung function before and after this medical procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of the TTE diameter after large-volume thoracentesis
change of the UCG diameter of the patients, including : Left ventricular: Left ventricular end-diastolic diameter(LVEDD）, Left ventricular end-systolic diameter（LVESD）, Left ventricular end-diastolic volume （LVEDV ）, Left ventricular end-systolic volume（ LVESV）, Left ventricular ejection fraction（LVEF）,Stroke volume（SV）,Cardiac output（CO），left ventricular diastolic function, including：E、A、E/A、E/Em、Em、Am（By PW\&DTI）；Global longitudinal strain(GLS）; right ventricular：Basal and mid-cavity transversal right ventricular diameter, right ventricular free wall thickness, Tricuspid annular plane systolic excursion（TAPSE）, Fractional area change（FAC）, right ventricular systolic strain, Left and right atrial volume, coronary artery diameter
Measured: baseline, immediately after drainage, 24 h after the thoracentesis
Secondary outcomes (1)
changes of the distances on 6-MWT after large-volume thoracentesis
6-MWT is the distances on the 6-minute walk test
Measured: baseline, immediately after drainage, 24 h after the thoracentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Pleural EffusionStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Huanzhong, Beijing Chao Yang Hospital
- Investigators
- Huanzhong Shi, Ph.D, Study director, Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548221
- Sponsor's protocol ID
- TTE and LVPE
- Acronym
- TTE
- Status last verified
- Sep 2015
- First submitted
- 6 Sep 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Heart Function Using Transthoracic Echocardiogram (TTE) Following Thoracentesis on Large-volume Pleural Effusions
- ClinicalTrials.gov ID
- NCT02548221
- Acronym / sponsor ID
- TTE / TTE and LVPE
- Conditions
- Bilateral Pleural Effusion
- Keywords
- Thoracentesis, Pleural Effusions, Transthoracic echocardiogram, Lung volume measurements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Sep 2015 (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.
The physiologic basis for relief from dyspnea after therapeutic thoracentesis remains poorly understood. Improvement of the heart and lung function may contribute to the dyspnea relief. But there is no data support this phenomenon. Transthoracic echocardiogram (TTE) is a non-invasive viewing of the heart, which can quickly assess the heart function through real-time images. The investigators performed thoracentesis on patients with large-volume pleural effusions, and utilized TTE to access the change of heart and lung function before and after this medical procedure.
Detailed description
Patients with large pleural effusions often experience dramatic and immediate relief from dyspnea after therapeutic thoracentesis. Although this is a well-recognized phenomenon, the physiologic basis for such relief remains poorly understood. Primary physiologic basis for the relief in dyspnea after thoracentesis may include the improvement of the heart and lung function. In some cases the improvement in breathlessness cannot be attributed to the improvement of gas exchange, due to the atelectatic lung(not fully expansion of the lung). Transthoracic echocardiogram (TTE) is a non-invasive, real-time viewing of the internal parts of the heart using ultrasound, which can get highly accurate and quick assessment of the various heart images, though which doctors can quickly assess a patient's heart valves and degree of heart muscle contraction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with unilateral or bilateral pleural effusion, with at least 500ml amount of effusion are enrolled in this study. Study population include malignant pleural effusion, tuberculosis pleural effusion, parapneumonic effusion, and a variety of causes for transudative pleural effusion.
Key inclusion criteria (3 listed)
- the estimated amount of effusion is above 500 ml;
- Drainage was not performed within 1 month before admission;
- assigned informed consent.
Key exclusion criteria (11 listed)
- physical weakness which is difficult to withstand the thoracentesis;
- the happening of serious pleural reaction or reexpansion pulmonary edema on previous thoracentesis;
- allergy to the anesthetic;
- coagulation dysfunction, severe bleeding tendency;
- serious mental illness who do not cooperate;
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 |
|---|---|---|
| transthoracic echocardiogramThoracentesis was performed on patients with large-volume pleural effusions, and TTE was utilized to access the change of heart and lung function before and after this medical procedure. | Device | – |
Primary outcome
changes of the TTE diameter after large-volume thoracentesis
Time frame: baseline, immediately after drainage, 24 h after the thoracentesis
change of the UCG diameter of the patients, including : Left ventricular: Left ventricular end-diastolic diameter(LVEDD）, Left ventricular end-systolic diameter（LVESD）, Left ventricular end-diastolic volume （LVEDV ）, Left ventricular end-systolic volume（ LVESV）, Left ventricular ejection fraction（LVEF）,Stroke volume（SV）,Cardiac output（CO），left ventricular diastolic function, including：E、A、E/A、E/Em、Em、Am（By PW\&DTI）；Global longitudinal strain(GLS）; right ventricular：Basal and mid-cavity transversal right ventricular diameter, right ventricular free wall thickness, Tricuspid annular plane systolic excursion（TAPSE）, Fractional area change（FAC）, right ventricular systolic strain, Left and right atrial volume, coronary artery diameter
1 secondary outcome
changes of the distances on 6-MWT after large-volume thoracentesis
Time frame: baseline, immediately after drainage, 24 h after the thoracentesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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.
Huanzhong Shi, Ph.D study director
Department of Respiratory and Critical Care Medicine, Beijing Chaoyang 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 Bilateral Pleural Effusion, run by Beijing Chao Yang 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zheng wang, Ph.D (+86-13810450600, azheng178@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of the TTE diameter after large-volume thoracentesis (time frame: baseline, immediately after drainage, 24 h after the thoracentesis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2015.