Relationship Between Pleural Elastance and Effectiveness of Pleurodesis on Recurrent Malignant Pleural Effusion
The objective of this study is to analyze the correlation between pleural elastance and the radiological effectiveness (measured by chest tomography) of pleurodesis performed via catheters in patients with RMPE. The secondary objectives of this study are: correlate pleural elastance with quality of life, analysis of dyspnea and pain after the procedure, clinical effectiveness, complications and mortality in 30 days.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Relationship Between Pleural Elastance and Effectiveness of Pleurodesis on Recurrent Malignant Pleural Effusion|
- Radiological Effective [ Time Frame: 1 month after the inclusion ] [ Designated as safety issue: No ]The effectiveness will be measured by radiographic tomography of the chest. Will be measured volumes of pleural fluid in chest CT after placement of the drain and 1 month after pleurodesis
- Clinical Effectiveness [ Time Frame: 1 months after inclusion; each 3 months after inclusion until death ] [ Designated as safety issue: No ]The clinical effectiveness will be considered a binary variable (success or failure). We will consider failure of pleurodesis when, at any time of follow-up procedure was necessary some new procedure for emptying pleural effusion, is puncture, drainage or thoracoscopy. Such procedures shall be appointed by the surgical team of the Pleural Diseases Clinic of the HCFMUSP considering clinical criteria (symptoms: dyspnea, cough and chest pain) and radiological (new fluid accumulation in chest tomography).
- Analysis of Quality of Life [ Time Frame: at inclusion, 1 month after inclusion, each 3 months after inclusion until death ] [ Designated as safety issue: No ]To analyze the quality of life we use the WHOQoL-Bref. The WHOQOL-Bref is a reduced version of the questionnaire of quality of life developed by the World Health Organization multi-cultural context, aiming to cover as many countries and cultures as possible and thus can be used internationally, allowing the comparison between the results obtained in different locations.
- Analysis of Pain [ Time Frame: at inclusion, 1 month after inclusion; each 3 months after inclusion until death ] [ Designated as safety issue: No ]Pain assessment will be made by patient´s quantifying of the Visual Analog Scale of Pain. The questionnaire will be applied by the same investigator during the initial evaluation, the returns one month after the procedure and then quarterly.
- Analysis of dyspnea [ Time Frame: at inclusion, 1 month after inclusion; each 3 months after inclusion until death ] [ Designated as safety issue: No ]The analysis of dyspnea will be made by quantifying the functionality with the dyspnea scale of the British Medical Research Council (MRC). The questionnaire will be applied by the same investigator during the initial evaluation, the returns one month after the procedure and then quarterly.
- Security Analysis [ Time Frame: at inclusion, 1 month after inclusion, each 3 months after inclusion until death ] [ Designated as safety issue: Yes ]For the analysis of safety procedures shall be deemed times of hospitalization and drainage and occurrence of complications. Such data will be obtained during the inpatient and outpatient follow-up as previously described. Other complications will be recorded as the occurrence and graded according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||January 2016|
Patients with Malignant pleural effusion according to inclusion and exclusion criteria.
Procedure: Pleural elastance
The pleural pressure level will be zero at the time of the insertion site of the drain on the skin. The pleural pressure is set to the value measured at end-expiration. The pleural pressure is measured at baseline, after withdrawal of 10 ml of liquid and thereafter every 400 ml of pleural effusion evacuated to the pressure to be negative, from that moment the measurement will occur every 200 ml of pleural effusion drained to obtain 800 ml of liquid. Patients that are removed less than 800 ml of liquid will be excluded from the protocol. The pleural elastance is then calculated in cm H2O / L and the data placed in a pressure curve by volume.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819363
|Contact: Pedro HX Araújo, MDemail@example.com|
|Contact: Ricardo M Terra, MD, PhDfirstname.lastname@example.org|
|INCOR - Heart Institute||Recruiting|
|São Paulo, SP, Brazil, 05403-000|
|Contact: Pedro HX Araújo, MD 55-11-8316-4791 email@example.com|
|Contact: Ricardo M Terra, MD, PhD 55-11-9975-1178 firstname.lastname@example.org|
|Principal Investigator: Pedro HX Araújo, MD|
|Principal Investigator: Ricardo M Terra, MD, PhD|
|Sub-Investigator: Victor Ishii, student|
|Sub-Investigator: Rodrigo C Chate, MD|
|Sub-Investigator: Paulo M Pêgo-Fernandes, MD, PhD|
|Sub-Investigator: Francisco S Vargas, MD, PhD|
|Sub-Investigator: Fabio B Jatene, MD, PhD|
|Study Chair:||Ricardo M Terra, MD, PhD||Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo|