Effects of Respiratory Physiotherapy on Pleural Effusion

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756742
• Other study ID #: DF0038UG
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: December 20, 2012
• Start date: February 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Other:
• Respiratory physiotherapy
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.
• Conservative treatment
Conservative medical treatment intervention for pleural effusion.

Locations

Country	Name	City	State
Spain	Universitary Hospital San Cecilio	Granada	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of the hospital stay	Length of stay was defined as the number of days between admission and discharge.	baseline, 12 months
Secondary	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.