Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion
Effect of Therapeutic Thoracentesis on Cardiopulmonary Function in Patients With Congestive Heart Failure Complicated With Large to Massive Pleural Effusion
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedDecember 30, 2010
December 1, 2010
2.3 years
February 25, 2008
December 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
15 minutes after therapeutic thoracentesis
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University Hospital
Taipei, 110, Taiwan
Related Publications (1)
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.
PMID: 20646242DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chi-Li Chung, MD, PhD
Department of Internal Medicine, Taipei Medical University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 6, 2008
Study Start
March 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
December 30, 2010
Record last verified: 2010-12