Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion
Primary Purpose
Congestive Heart Failure, Transudative Pleural Effusion
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Therapeutic thoracentesis
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring congestive heart failure, thoracentesis, transudative pleural effusions
Eligibility Criteria
Inclusion Criteria:
- transudative pleural effusion established by the criteria of Light
- the effusion occupying at least half of one hemithorax shown on chest radiography
- symptoms of respiratory distress
- diagnosis of congestive heart failure
Exclusion Criteria:
- severe uncontrolled coagulopathy
- unstable hemodynamics
- diagnosis of liver cirrhosis, chronic obstructive pulmonary disease,asthma and/or any parenchymal lung disease, such as pneumonia, fibrosis or malignancy.
Sites / Locations
- Taipei Medical University Hospital
Outcomes
Primary Outcome Measures
Vital signs, minute volume, expiratory tidal volume, dynamic compliance, arterial oxygen saturation and arterial blood gases, the volume of pleural fluid removed, and the changes in pleural liquid pressure and pleural space elastance
Secondary Outcome Measures
Full Information
NCT ID
NCT00629538
First Posted
February 25, 2008
Last Updated
December 28, 2010
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00629538
Brief Title
Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion
Official Title
Effect of Therapeutic Thoracentesis on Cardiopulmonary Function in Patients With Congestive Heart Failure Complicated With Large to Massive Pleural Effusion
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Transudative pleural effusions are a common manifestation of patients with congestive heart failure. Severe dyspnea and respiratory failure may develop in those with large effusions, which in general show poor response to medical treatment. Therapeutic thoracenteses (TT) may be indicated in these patients and can produce marked relief of symptoms. However, the underlying effect of TT on gas exchange and respiratory mechanics in theses patients remains unclear. The researchers' hypothesis is that,TT may improve arterial oxygenation and respiratory mechanics in patients with congestive heart failure complicated by large pleural effusions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Transudative Pleural Effusion
Keywords
congestive heart failure, thoracentesis, transudative pleural effusions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Therapeutic thoracentesis
Intervention Description
Thoracentesis was performed with drainage of 500 ml of pleural fluid first and every 200 ml thereafter until pleural pressure was lower than -20 cm H2O, chest discomfort developed, or no more pleural fluid could be removed.
Primary Outcome Measure Information:
Title
Vital signs, minute volume, expiratory tidal volume, dynamic compliance, arterial oxygen saturation and arterial blood gases, the volume of pleural fluid removed, and the changes in pleural liquid pressure and pleural space elastance
Time Frame
15 minutes after therapeutic thoracentesis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
transudative pleural effusion established by the criteria of Light
the effusion occupying at least half of one hemithorax shown on chest radiography
symptoms of respiratory distress
diagnosis of congestive heart failure
Exclusion Criteria:
severe uncontrolled coagulopathy
unstable hemodynamics
diagnosis of liver cirrhosis, chronic obstructive pulmonary disease,asthma and/or any parenchymal lung disease, such as pneumonia, fibrosis or malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Li Chung, MD, PhD
Organizational Affiliation
Department of Internal Medicine, Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20646242
Citation
Chen WL, Chung CL, Hsiao SH, Chang SC. Pleural space elastance and changes in oxygenation after therapeutic thoracentesis in ventilated patients with heart failure and transudative pleural effusions. Respirology. 2010 Aug;15(6):1001-8. doi: 10.1111/j.1440-1843.2010.01812.x. Epub 2010 Jul 20.
Results Reference
derived
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Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion
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