Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion

Not Applicable

Completed

• Conditions: Infection; Pleural Diseases
• Interventions: Other: Chest physiotherapy

• Registration Number: NCT02359383
• Lead Sponsor: Hospital de Granollers

Brief Summary

Chest physiotherapy (CP) facilitates the absorption of fluid in the pleural cavity and reduces the formation of fibrous adhesions in patients with pleural infection, allowing a faster clinical, functional and radiological improve. The aim of the study is to determine if the CP associated with conventional medical treatment (CT) improves functional sequelae secondary to pleural infectious.

Detailed Description

This is a multicenter, prospective and randomized trial. Objective: To determine if the Chest physiotherapy (CP) associated with conventional medical treatment (CT) improves functional sequelae secondary to pleural infectious disease, defined as an increased of 15% in Vital Functional Capacity (VFC). Adult patients with diagnosis of pleural infection will be included and randomized into two branches: control group - only CT and interventional one - CT plus CP.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of infectious pleural effusion
• Failure to meet any exclusion criteria.

Exclusion Criteria

• Hemothorax.
• Malignant pleural effusion.
• Severe comorbidities (end-stage disease, neuromuscular diseases, etc)
• Previous ribcage and/or diaphragmatic pathology.
• Pregnancy.
• Previous respiratory rehabilitation program completed.
• Prior pleural pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chest Physiotherapy group	Chest physiotherapy	Conventional medical treatment plus Chest Physiotherapy

Primary Outcome Measures

Name	Time	Method
Change in improving lung function	3 months	To determine if Respiratory Physiotherapy (RP) associated with conventional medical treatment (CT) improves functional sequelae secondary to infectious pleural effusion. All patients will performed spirometric studies at the beginning of the study, at 3 and 6 month.

Secondary Outcome Measures

Name	Time	Method
Change in resolution of pleural effusion	3 months	To analysed if CP allows faster resolution of pleural effusion. A simple thoracic Rx will be performed to assess radiological changes every month till resolution of pleural sequelae.
Reduce hospital stay	3 months	To assess if CP added to medical therapy in patients with infectious pleural effusion decreased hospital stay

Trial Locations

Locations (1)

Inmaculada Castillo; 🇪🇸 Granollers, Barcelona, Spain