Impact of Large-Volume Pleural Effusions on Heart Function

NCT02548221 | Unknown

• 1 other identifier: TTE and LVPE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bilateral Pleural Effusion

Keywords

Thoracentesis; Pleural Effusions; Transthoracic echocardiogram; Lung volume measurements

Outcome Measures

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

  baseline, immediately after drainage, 24 h after the thoracentesis

Secondary Outcomes (1)

• changes of the distances on 6-MWT after large-volume thoracentesis

  baseline, immediately after drainage, 24 h after the thoracentesis

Interventions

transthoracic echocardiogram DEVICE

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.

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine and Beijing Chaoyang Hospital, Capital Medical University

Beijing, 100020, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Huanzhong Shi, Ph.D

  Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital,

  STUDY DIRECTOR

Central Study Contacts

zheng wang, Ph.D

CONTACT

+86-13810450600; azheng178@163.com

Huanzhong Shi, Ph.D and MD

CONTACT

+86-13911791398; shihuanzhong@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 14, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 14, 2015

Record last verified: 2015-09

Locations

CN (1)