Impact of Large-Volume Pleural Effusions on Heart Function

Bilateral Pleural Effusion Clinical Trial

— TTE  

Official title:

The Assessment of Heart Function Using Transthoracic Echocardiogram (TTE) Following Thoracentesis on Large-volume Pleural Effusions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02548221
• Other study ID #: TTE and LVPE
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2015
• Last updated: September 11, 2015
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Beijing Chao Yang Hospital
• Contact: zheng wang, Ph.D
• Phone: +86-13810450600
• Email: azheng178[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bilateral Pleural Effusion
• Pleural Effusion

Intervention

Device:
• transthoracic 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.

Locations

Country	Name	City	State
China	Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chaoyang Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No