NCT00560521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
Last Updated

November 19, 2007

Status Verified

November 1, 2007

First QC Date

November 16, 2007

Last Update Submit

November 16, 2007

Conditions

Keywords

CPAPTuberculosisPleural effusionPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Evaluate of pleural effusion volume

    one month

Study Arms (1)

1

ACTIVE COMPARATOR
Behavioral: CPAP

Interventions

CPAPBEHAVIORAL

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of pleural tuberculosis.
  • Patients 18 years of age and older.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rio de Janeiro, Rio de Janeiro, 21941913, Brazil

Location

Related Publications (8)

  • 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.

    PMID: 9778201BACKGROUND
  • Masip J. Non-invasive ventilation. Heart Fail Rev. 2007 Jun;12(2):119-24. doi: 10.1007/s10741-007-9012-7.

    PMID: 17492379BACKGROUND
  • Seiscento M, Conde MB, Dalcolmo MM. [Tuberculous pleural effusions]. J Bras Pneumol. 2006;32 Suppl 4:S174-81. doi: 10.1590/s1806-37132006000900003. Portuguese.

    PMID: 17273621BACKGROUND
  • 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.

    PMID: 12598215BACKGROUND
  • 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.

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

  • 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.

  • 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.

MeSH Terms

Conditions

TuberculosisPleural Effusion

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPleural DiseasesRespiratory Tract Diseases

Study Officials

  • Juliana F Oliveira, MD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR
  • Marcus B. Conde, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR
  • Rosana S. Rodrigues, MD

    Universidade Federal do Rio de Janeiro

    STUDY CHAIR
  • Sara L. Menezes, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR
  • Ana L. Boechat, MD

    Universidade Federal do Rio de Janeiro

    STUDY CHAIR
  • Fernanda C. Mello, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

March 1, 2005

Study Completion

March 1, 2007

Last Updated

November 19, 2007

Record last verified: 2007-11

Locations