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OpenTrials
Completed

NCT Number: NCT00629538

Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large 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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic thoracentesis

Procedure

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 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

    Time frame: 15 minutes after therapeutic thoracentesis

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

Effect of Therapeutic Thoracentesis on Cardiopulmonary Function in Patients With Congestive Heart Failure Complicated With Large to Massive Pleural Effusion

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2008
Registry last updated
Dec 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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