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Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00560521
First received: November 16, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 16, 2007
November 16, 2007
March 2005
Not Provided
Evaluate of pleural effusion volume [ Time Frame: one month ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion
Effect of Continuous Positive Airway Pressure on Fluid Absorption Among Patients With Pleural Effusion Due to Tuberculosis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Tuberculosis
  • Pleural Effusion
Behavioral: CPAP
Frequency of three times a week, using a positive end expiratory pressure (PEEP) of 10 mmH2O for 30 minutes for four weeks.
Active Comparator: 1
Intervention: Behavioral: CPAP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00560521
Oliveira-1
Yes
Not Provided
Universidade Federal do Rio de Janeiro
Not Provided
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
Universidade Federal do Rio de Janeiro
November 2007

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