Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion
This study has been completed.
Sponsor:
Taipei Medical University Hospital
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
| Tracking Information | |||||
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| First Received Date ICMJE | February 25, 2008 | ||||
| Last Updated Date | December 28, 2010 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00629538 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion | ||||
| Official Title ICMJE | Effect of Therapeutic Thoracentesis on Cardiopulmonary Function in Patients With Congestive Heart Failure Complicated With Large to Massive Pleural Effusion | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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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| Study Arm (s) | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00629538 | ||||
| Other Study ID Numbers ICMJE | TMUHIRB20070304 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Chung, Chi-Li/Chest physician of Department of Internal Medicine, Taipei Medical University Hospital | ||||
| Study Sponsor ICMJE | Taipei Medical University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Taipei Medical University Hospital | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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