search
Back to results

Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion

Primary Purpose

Tuberculosis, Pleural Effusion

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis focused on measuring CPAP, Tuberculosis, Pleural effusion, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Evaluate of pleural effusion volume

Secondary Outcome Measures

Full Information

First Posted
November 16, 2007
Last Updated
November 16, 2007
Sponsor
Universidade Federal do Rio de Janeiro
search

1. Study Identification

Unique Protocol Identification Number
NCT00560521
Brief Title
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

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pleural Effusion
Keywords
CPAP, Tuberculosis, Pleural effusion, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
CPAP
Intervention Description
Frequency of three times a week, using a positive end expiratory pressure (PEEP) of 10 mmH2O for 30 minutes for four weeks.
Primary Outcome Measure Information:
Title
Evaluate of pleural effusion volume
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana F Oliveira, MD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcus B. Conde, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosana S. Rodrigues, MD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara L. Menezes, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana L. Boechat, MD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fernanda C. Mello, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clementino Fraga Filho University Hospital- Federal University of Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
21941913
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
9778201
Citation
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.
Results Reference
background
PubMed Identifier
17492379
Citation
Masip J. Non-invasive ventilation. Heart Fail Rev. 2007 Jun;12(2):119-24. doi: 10.1007/s10741-007-9012-7.
Results Reference
background
PubMed Identifier
17273621
Citation
Seiscento M, Conde MB, Dalcolmo MM. [Tuberculous pleural effusions]. J Bras Pneumol. 2006;32 Suppl 4:S174-81. doi: 10.1590/s1806-37132006000900003. Portuguese.
Results Reference
background
PubMed Identifier
12598215
Citation
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.
Results Reference
background
PubMed Identifier
7301718
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.
Results Reference
result
PubMed Identifier
9150338
Citation
Ferrer J. Pleural tuberculosis. Eur Respir J. 1997 Apr;10(4):942-7.
Results Reference
result
PubMed Identifier
12603352
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. doi: 10.1046/j.1440-1681.2003.03804.x.
Results Reference
result
PubMed Identifier
20464170
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.
Results Reference
derived

Learn more about this trial

Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion

We'll reach out to this number within 24 hrs