Clinical trial NCT02359383: Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion
Official title: Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Diseases
Infection
Keywords: pleural disease
infecTion
chest physiotherapy
Lead sponsor: Hospital de Granollers
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2015-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in improving lung function
timeFrame: 3 months
Secondary outcomes:
measure: Change in resolution of pleural effusion
timeFrame: 3 months
measure: Reduce hospital stay
timeFrame: 3 months
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Inmaculada Castillo
state: Barcelona
Study officials:
affiliation: Hospital General de Granollers
name: Inmaculada Castillo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villena Garrido V, Cases Viedma E, Fernandez Villar A, de Pablo Gafas A, Perez Rodriguez E, Porcel Perez JM, Rodriguez Panadero F, Ruiz Martinez C, Salvatierra Velazquez A, Valdes 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. English, Spanish.
citation: Villena Garrido V, Ferrer Sancho J, Hernandez Blasco L, de Pablo Gafas A, Perez Rodriguez E, Rodriguez Panadero F, Romero Candeira S, Salvatierra Velazquez A, Valdes Cuadrado L; Area de Tecnicas y Trasplantes. SEPAR. [Diagnosis and treatment of pleural effusion]. Arch Bronconeumol. 2006 Jul;42(7):349-72. doi: 10.1016/s1579-2129(06)60545-4. No abstract available. Spanish.
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. No abstract available.
citation: Porcel JM, Light RW. [Parapneumonic pleural effusions and empyema in adults:current practice]. Rev Clin Esp. 2009 Nov;209(10):485-94. doi: 10.1016/s0014-2565(09)72634-7. Spanish.
citation: Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.
citation: 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. doi: 10.1378/chest.118.4.1158.