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Completed

NCT Number: NCT00560521

Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clementino Fraga Filho University Hospital- Federal University of Rio de Janeiro

Rio de Janeiro, 21941913, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

CPAP

Behavioral

Frequency of three times a week, using a positive end expiratory pressure (PEEP) of 10 mmH2O for 30 minutes for four weeks.

Primary outcomes

  1. Evaluate of pleural effusion volume

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

Effect of Continuous Positive Airway Pressure on Fluid Absorption Among Patients With Pleural Effusion Due to Tuberculosis

Important dates

Study start
2005
Study completion
2007
First posted
Nov 19, 2007
Registry last updated
Nov 19, 2007

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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