Effectiveness of a Program of Respiratory Physiotherapy on Pleural Effusion: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 112
- Locations
- 2
- Primary Endpoint
- Assessment of the severity of respiratory disease
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Respiratory physiotherapy
54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.
Intervention: Respiratory physiotherapy (Other)
Conservative treatment
49 people were recruited in this group. These participants received conservative medical treatment intervention
Intervention: Conservative treatment (Other)
Outcomes
Primary Outcomes
Assessment of the severity of respiratory disease
Time Frame: 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 Outcomes
- Severity in the pleural effusion repercussion(baseline, 12 months.)
- Length of the hospital stay(baseline, 12 months)
Investigators
Marie Carmen Valenza
Assistant professor
Universidad de Granada