Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion

Infection Clinical Trial

— FISIOPLEURA  

Official title:

Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359383
• Other study ID #: 20133001
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: June 2022

Study information

• Verified date: August 2022
• Source: Hospital de Granollers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Pleural Diseases
• Pleural Effusion

Intervention

Other:
• Chest physiotherapy
Depending on the location of the pleural effusion different techniques are performed: 1. Postural control techniques; 2. Secretions drainage techniques; 3. Thoracic expansion techniques; 4. Diaphragmatic mobility techniques.

Locations

Country	Name	City	State
Spain	Inmaculada Castillo	Granollers	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Granollers	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Colice GL, Curtis A, Deslauriers J, Heffner J, Light R, Littenberg B, Sahn S, Weinstein RA, Yusen RD. Medical and surgical treatment of parapneumonic effusions : an evidence-based guideline. Chest. 2000 Oct;118(4):1158-71. Review. Erratum in: Chest 2001 Jan;119(1):319. — View Citation

Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. Review. — View Citation

Porcel JM, Light RW. [Parapneumonic pleural effusions and empyema in adults:current practice]. Rev Clin Esp. 2009 Nov;209(10):485-94. Review. Spanish. — View Citation

Skouras V, Awdankiewicz A, Light RW. What size parapneumonic effusions should be sampled? Thorax. 2010 Jan;65(1):91. doi: 10.1136/thx.2008.112797. — View Citation

Villena Garrido V, Cases Viedma E, Fernández Villar A, de Pablo Gafas A, Pérez Rodríguez E, Porcel Pérez JM, Rodríguez Panadero F, Ruiz Martínez C, Salvatierra Velázquez A, Valdés Cuadrado L. Recommendations of diagnosis and treatment of pleural effusion. Update. Arch Bronconeumol. 2014 Jun;50(6):235-49. doi: 10.1016/j.arbres.2014.01.016. Epub 2014 Mar 31. Review. English, Spanish. — View Citation

Villena Garrido V, Ferrer Sancho J, Hernández Blasco L, de Pablo Gafas A, Pérez Rodríguez E, Rodríguez Panadero F, Romero Candeira S, Salvatierra Velázquez A, Valdés Cuadrado L; Area de Tecnicas y Trasplantes. SEPAR. [Diagnosis and treatment of pleural effusion]. Arch Bronconeumol. 2006 Jul;42(7):349-72. Review. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in improving lung function	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.	3 months
Secondary	Change in resolution of pleural effusion	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.	3 months
Secondary	Reduce hospital stay	To assess if CP added to medical therapy in patients with infectious pleural effusion decreased hospital stay	3 months