Effects of Respiratory Physiotherapy on Pleural Effusion

Not Applicable

Completed

• Conditions: Pleural Effusion
• Interventions: Other: Respiratory physiotherapy; Other: Conservative treatment

• Registration Number: NCT01756742
• Lead Sponsor: Universidad de Granada

Brief Summary

Pleural effusion and the complexity of diagnosis and treatment make planning and delivering care challenging. Respiratory physiotherapy is recommended, and should be applied during the first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a University Hospital.

Detailed Description

Approximately 1.5 million patients are diagnosed with pleural effusion each year in the United States . Pleural effusion (PE) is an accumulation of fluid in the pleural space that is classified as transudate or exudate according to its composition and underlying pathophysiology. The goal in the management of pleural effusion is to provide symptomatic relief by removing fluid from the pleural space and to allow the treatment of the underlying disease. While some authors (REF) propose respiratory physiotherapy, in the majority of the cases only the medical treatment combined with the pleural fluid removal by thoracentesis are the most common practice. The objective of this study is verify the effectiveness of respiratory physiotherapy in pleural effusion

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2011-01
• Study Completion: 2012-03
• Status Verified: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Last Update Submitted: 2012-12-20
• Study First Posted: 2012-12-27
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Diagnosis of pleural effusion based on the presence of a consistent radiological finding on simple posteroanterior and lateral chest X-rays, and decubitus lateral in cases of small PE.

Exclusion Criteria

• Non diagnosis of pleural effusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Respiratory physiotherapy	Respiratory physiotherapy	54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.
Conservative treatment	Conservative treatment	49 people were recruited in this group. These participants received conservative medical treatment intervention

Primary Outcome Measures

Name	Time	Method
Assessment of the severity of respiratory disease	baseline, 12 months	A spirometry is used to assess severity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second, and the forced expiratory flow over the middle one half of the forced vital capacity.

Secondary Outcome Measures

Name	Time	Method
Length of the hospital stay	baseline, 12 months	Length of stay was defined as the number of days between admission and discharge.
Severity in the pleural effusion repercussion	baseline, 12 months.	The chest radiograph has been the initial diagnostic tool for the detection and evaluation of pleural effusion. The severity was codified from 0(normal) to 10 (very severe) by a radiologist with more than 8 years of experience.

Trial Locations

Locations (1)

Universitary Hospital San Cecilio; 🇪🇸 Granada, Andalucia, Spain