Impact of Large-Volume Pleural Effusions on Heart Function (TTE)

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.

Study Overview

• Status: Unknown
• Conditions: Bilateral Pleural Effusion
• Intervention / Treatment: Device: transthoracic echocardiogram

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100020
    • Recruiting
    • Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chaoyang Hospital, Capital Medical University
    • Contact: zheng wang, Ph.D; Phone Number: +86-13810450600; Email: azheng178@163.com
    • Contact: huanzhong shi, Ph.D; Phone Number: +86-13911791398; Email: shihuanzhong@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, immediately after drainage, 24 h after the thoracentesis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of the distances on 6-MWT after large-volume thoracentesis	6-MWT is the distances on the 6-minute walk test	baseline, immediately after drainage, 24 h after the thoracentesis

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Study Director: Huanzhong Shi, Ph.D, Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital,

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: September 6, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Thoracentesis; Transthoracic echocardiogram; Pleural Effusions; Lung volume measurements
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: TTE and LVPE