Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion

This study has been completed.
Sponsor:
Information provided by:
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00629538
First received: February 25, 2008
Last updated: December 28, 2010
Last verified: December 2010

February 25, 2008
December 28, 2010
March 2007
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Blood pressure, respiratory rate, heart rate, minute volume, expiratory tidal volume, pulse oxygen saturation (SpO2), arterial blood gases and total amount of pleural effusion drained [ Time Frame: 15 minutes after therapeutic thoracentesis ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00629538 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congestive Heart Failure
  • Transudative Pleural Effusion
Procedure: Therapeutic thoracentesis
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.
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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. Epub 2010 Jul 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00629538
TMUHIRB20070304
Yes
Chung, Chi-Li/Chest physician of Department of Internal Medicine, Taipei Medical University Hospital
Taipei Medical University Hospital
Not Provided
Principal Investigator: Chi-Li Chung, MD, PhD Department of Internal Medicine, Taipei Medical University Hospital
Taipei Medical University Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP