Impact of Large-Volume Pleural Effusions on Heart Function

• Conditions: Bilateral Pleural Effusion

• Registration Number: NCT02548221
• Lead Sponsor: Beijing Chao Yang Hospital

Brief 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.

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 Timeline

• Status Verified: 2015-09
• Study Start: 2015-09
• Study First Submitted: 2015-09-06
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Posted: 2015-09-14
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes of the TTE diameter after large-volume thoracentesis	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

Secondary Outcome Measures

Name	Time	Method
changes of the distances on 6-MWT after large-volume thoracentesis	baseline, immediately after drainage, 24 h after the thoracentesis	6-MWT is the distances on the 6-minute walk test

Trial Locations

Locations (1)

Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, China