Clinical trial NCT00560521: Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion
Official title: Effect of Continuous Positive Airway Pressure on Fluid Absorption Among Patients With Pleural Effusion Due to Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Pleural Effusion
Keywords: CPAP
Tuberculosis
Pleural effusion
Physiotherapy
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2007-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Evaluate of pleural effusion volume
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Clementino Fraga Filho University Hospital- Federal University of Rio de Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Juliana F Oliveira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Marcus B. Conde, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Rosana S. Rodrigues, MD
role: STUDY_CHAIR
affiliation: Universidade Federal do Rio de Janeiro
name: Sara L. Menezes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Ana L. Boechat, MD
role: STUDY_CHAIR
affiliation: Universidade Federal do Rio de Janeiro
name: Fernanda C. Mello, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Oliveira JF, Mello FC, Rodrigues RS, Boechat AL, Conde MB, Menezes SL. Effect of continuous positive airway pressure on fluid absorption among patients with pleural effusion due to tuberculosis. Rev Bras Fisioter. 2010 Mar-Apr;14(2):127-32. doi: 10.1590/s1413-35552010005000001. Epub 2010 Apr 30.