Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion

NCT ID: NCT00560521

Last Updated: 2007-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Tuberculosis Pleural Effusion

Keywords

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CPAP Tuberculosis Pleural effusion Physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type BEHAVIORAL

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

Interventions

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CPAP

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Principal Investigators

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Juliana F Oliveira, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Marcus B. Conde, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Rosana S. Rodrigues, MD

Role: STUDY_CHAIR

Universidade Federal do Rio de Janeiro

Sara L. Menezes, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Ana L. Boechat, MD

Role: STUDY_CHAIR

Universidade Federal do Rio de Janeiro

Fernanda C. Mello, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

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

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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Valdes L, Alvarez D, San Jose E, Penela P, Valle JM, Garcia-Pazos JM, Suarez J, Pose A. Tuberculous pleurisy: a study of 254 patients. Arch Intern Med. 1998 Oct 12;158(18):2017-21. doi: 10.1001/archinte.158.18.2017.

Reference Type BACKGROUND
PMID: 9778201 (View on PubMed)

Masip J. Non-invasive ventilation. Heart Fail Rev. 2007 Jun;12(2):119-24. doi: 10.1007/s10741-007-9012-7.

Reference Type BACKGROUND
PMID: 17492379 (View on PubMed)

Seiscento M, Conde MB, Dalcolmo MM. [Tuberculous pleural effusions]. J Bras Pneumol. 2006;32 Suppl 4:S174-81. doi: 10.1590/s1806-37132006000900003. Portuguese.

Reference Type BACKGROUND
PMID: 17273621 (View on PubMed)

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. doi: 10.1164/rccm.2111019.

Reference Type BACKGROUND
PMID: 12598215 (View on PubMed)

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.

Reference Type RESULT
PMID: 7301718 (View on PubMed)

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

Reference Type RESULT
PMID: 9150338 (View on PubMed)

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. doi: 10.1046/j.1440-1681.2003.03804.x.

Reference Type RESULT
PMID: 12603352 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20464170 (View on PubMed)

Other Identifiers

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Oliveira-1

Identifier Type: -

Identifier Source: org_study_id