Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560521
• Other study ID #: Oliveira-1
• Status: Completed
• Phase: N/A
• First received: November 16, 2007
• Last updated: November 16, 2007
• Start date: March 2005
• Est. completion date: March 2007

Study information

• Verified date: November 2007
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pleural Effusion
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Brazil	Clementino Fraga Filho University Hospital- Federal University of Rio de Janeiro	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Conde MB, Loivos AC, Rezende VM, Soares SL, Mello FC, Reingold AL, Daley CL, Kritski AL. Yield of sputum induction in the diagnosis of pleural tuberculosis. Am J Respir Crit Care Med. 2003 Mar 1;167(5):723-5. — View Citation

Ferrer J. Pleural tuberculosis. Eur Respir J. 1997 Apr;10(4):942-7. Review. — View Citation

Masip J. Non-invasive ventilation. Heart Fail Rev. 2007 Jun;12(2):119-24. Review. — View Citation

Seiscento M, Conde MB, Dalcolmo MM. [Tuberculous pleural effusions]. J Bras Pneumol. 2006;32 Suppl 4:S174-81. Portuguese. — View Citation

Valdés L, Alvarez D, San José E, Penela P, Valle JM, García-Pazos JM, Suárez J, Pose A. Tuberculous pleurisy: a study of 254 patients. Arch Intern Med. 1998 Oct 12;158(18):2017-21. — View Citation

Vandevenne A, Moyses B, Weitzenblum E, Carloz I, Methlin G. [Regional pulmonary function in unilateral sero-fibrinous pleural effusions and changes under the influence of treatment (author's transl)]. Poumon Coeur. 1981;37(3):223-8. French. — View Citation

Zhou A, Guo L, Tang L. Effect of an intrathoracic injection of sodium hyaluronic acid on the prevention of pleural thickening in excess fluid of tuberculous thoracic cavity. Clin Exp Pharmacol Physiol. 2003 Mar;30(3):203-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate of pleural effusion volume		one month