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Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560521
First Posted: November 19, 2007
Last Update Posted: November 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidade Federal do Rio de Janeiro
  Purpose

Tuberculosis (TB) remains as an important public health problem worldwide. Pleural tuberculosis is the most prevalent form of extrapulmonary presentation in immunocompetent patients.

The volume of effusion in the pleural space of patients with pleural TB may cause complications like restrictive ventilator lung functional disturb and/or pleural thickening. The respiratory physiotherapy can be adjuvant on treatment of pleural effusion tuberculosis throughout of various treatment technique.

The Continuous positive airway pressure (CPAP) is utilized in various pathologic, this improves lung mechanics by recruiting atelectatic alveoli, improving pulmonary compliance, and reducing the work of breathing.

The aim of this study is to determine the effect of CPAP on fluid absorption among patients with pleural effusion due tuberculosis.


Condition Intervention
Tuberculosis Pleural Effusion Behavioral: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Continuous Positive Airway Pressure on Fluid Absorption Among Patients With Pleural Effusion Due to Tuberculosis

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Evaluate of pleural effusion volume [ Time Frame: one month ]

Enrollment: 20
Study Start Date: March 2005
Study Completion Date: March 2007
Arms Assigned Interventions
Active Comparator: 1 Behavioral: CPAP
Frequency of three times a week, using a positive end expiratory pressure (PEEP) of 10 mmH2O for 30 minutes for four weeks.

Detailed Description:

This randomized and controlled trial compared the reduction of the pleural effusion volume of the group of patients using the anti-TB standard regimen to that using the anti-TB standard regimen AND adjuvant treatment of physical therapy during four weeks.

  • Control group: The patients received rifampicin, isoniazid and pyrazinamide daily(anti-TB standard regimen)
  • Interventional group: The patients received anti-tb standard regime and Continuous Positive Airway Pressure (CPAP) 3 times a week for 30 minutes with positive expiratory end pressure of 10 cmH2O.

Evaluation of the pleural effusion size: a helicoidal thoracic computed tomography (CT) was carried out in all patients enrolled. The valuation was conducted by two radiologists blinded for the treatment used, specifically trained for the purpose of the study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of pleural tuberculosis.
  • Patients 18 years of age and older.

Exclusion criteria:

  • Be under previous treatment of respiratory physiotherapy.
  • Irregular use or abandonment of the anti-TB standard regimen.
  • To fail one or more physiotherapy section.
  • To fail one or more radiological evaluation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560521


Locations
Brazil
Clementino Fraga Filho University Hospital- Federal University of Rio de Janeiro
Rio de Janeiro, Brazil, 21941913
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Principal Investigator: Juliana F Oliveira, MD Universidade Federal do Rio de Janeiro
Principal Investigator: Marcus B. Conde, PhD Universidade Federal do Rio de Janeiro
Study Chair: Rosana S. Rodrigues, MD Universidade Federal do Rio de Janeiro
Principal Investigator: Sara L. Menezes, PhD Universidade Federal do Rio de Janeiro
Study Chair: Ana L. Boechat, MD Universidade Federal do Rio de Janeiro
Principal Investigator: Fernanda C. Mello, PhD Universidade Federal do Rio de Janeiro
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00560521     History of Changes
Other Study ID Numbers: Oliveira-1
First Submitted: November 16, 2007
First Posted: November 19, 2007
Last Update Posted: November 19, 2007
Last Verified: November 2007

Keywords provided by Universidade Federal do Rio de Janeiro:
CPAP
Tuberculosis
Pleural effusion
Physiotherapy

Additional relevant MeSH terms:
Tuberculosis
Pleural Effusion
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pleural Diseases
Respiratory Tract Diseases