Effects of Respiratory Physiotherapy on Pleural Effusion

Study Overview
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Brief Summary
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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
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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

Official Title
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Effectiveness of a Program of Respiratory Physiotherapy on Pleural Effusion: a Randomized Controlled Trial

Conditions
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Pleural Effusion

Intervention / Treatment
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* Other: Respiratory physiotherapy
* Other: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory physiotherapy<br>54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention. | Other: Respiratory physiotherapy<br>* The respiratory physiotherapy intervention included: Mobilisation techniques: limb exercises (passive, active assisted, or active resisted) Chest physiotherapy: it included a Controlled breathing program, pursed lips breathing (PLB), active expiration and incentive spirometry.<br>* Other names: Respiratory techniques added to conservative treatment;|
| Placebo Comparator: Conservative treatment<br>49 people were recruited in this group. These participants received conservative medical treatment intervention | Other: Conservative treatment<br>* Conservative medical treatment intervention for pleural effusion.<br>* Other names: Medical treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the severity of respiratory disease | 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. | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the hospital stay | Length of stay was defined as the number of days between admission and discharge. | baseline, 12 months | 
| Severity in the pleural effusion repercussion | 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. | baseline, 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural Effusion, Respiratory physiotherapy, Length of stay