CClinicalTrials.gg
Status unknownNCT02548221TTEUpdated Sep 14, 2015

Impact of Large-Volume Pleural Effusions on Heart Function

An observational study in Bilateral Pleural Effusion, sponsored by Beijing Chao Yang Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-14.

Sponsored by Beijing Chao Yang Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
14 Years to 75 Years
Sex
All
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Study 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. 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.

02

Conditions studied

  • Bilateral Pleural Effusion

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Keywords

  • Thoracentesis
  • Pleural Effusions
  • Transthoracic echocardiogram
  • Lung volume measurements
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In context

Pleural Effusion

324 studies on the registry are indexed under Pleural Effusion; 62 are open to participants now.

This study's planned enrollment of 30 is below the median of 103 across 102 observational studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

Beijing Chao Yang Hospital is the lead sponsor of 135 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  1. the estimated amount of effusion is above 500 ml;
  2. Drainage was not performed within 1 month before admission;
  3. assigned informed consent.

Exclusion criteria

Exclusion Criteria:

  1. physical weakness which is difficult to withstand the thoracentesis;
  2. the happening of serious pleural reaction or reexpansion pulmonary edema on previous thoracentesis;
  3. allergy to the anesthetic;
  4. coagulation dysfunction, severe bleeding tendency;
  5. serious mental illness who do not cooperate;
  6. suspected with pleural hydatid disease;
  7. skin infection around supine positioning;
  8. severe heart function insufficiency who cannot lay on the back;
  9. for a variety of reasons that cannot accept regular follow-up;
  10. refused to sign the informed consent;
  11. other conditions that is not suitable for the test.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • Devicetransthoracic echocardiogram

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: baseline, immediately after drainage, 24 h after the thoracentesis

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Study locations

1 of 1 sites recruiting
  • Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chaoyang Hospital, Capital Medical University
    Beijing, 100020, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02548221
Lead sponsor
Beijing Chao Yang Hospital
Responsible party
Shi Huanzhong (Director of Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital, Beijing Chao Yang Hospital) — Principal investigator
First posted
Sep 14, 2015
Start date
Sep 2015
Primary completion
Dec 2015 (estimated)
Completion
Dec 2016 (estimated)
Last update
Sep 14, 2015

Study contacts

zheng wang, Ph.D
Contact
azheng178@163.com
+86-13810450600
Huanzhong Shi, Ph.D and MD
Contact
shihuanzhong@sina.com
+86-13911791398
Huanzhong Shi, Ph.D
study director · Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital,

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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