Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion

NCT ID: NCT02359383

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Pleural Diseases Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chest Physiotherapy group

Conventional medical treatment plus Chest Physiotherapy

Group Type ACTIVE_COMPARATOR

Chest physiotherapy

Intervention Type OTHER

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.

Control grup

Conventional medical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of infectious pleural effusion

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role collaborator

Hospital de Granollers

OTHER

Sponsor Role lead

Responsible Party

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Icastillo

Respiratory Therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inmaculada Castillo

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Granollers

Locations

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Inmaculada Castillo

Granollers, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 24698396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16945266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20029043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19889319 (View on PubMed)

Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.

Reference Type BACKGROUND
PMID: 16493154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11035692 (View on PubMed)

Other Identifiers

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20133001

Identifier Type: -

Identifier Source: org_study_id

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