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Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion (FISIOPLEURA)

Primary Purpose

Pleural Diseases, Infection

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chest physiotherapy
Sponsored by
Hospital de Granollers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Diseases focused on measuring pleural disease, infecTion, chest physiotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inmaculada Castillo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Chest Physiotherapy group

Control grup

Arm Description

Conventional medical treatment plus Chest Physiotherapy

Conventional medical treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Reduce hospital stay
To assess if CP added to medical therapy in patients with infectious pleural effusion decreased hospital stay

Full Information

First Posted
January 28, 2015
Last Updated
August 3, 2022
Sponsor
Hospital de Granollers
Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT02359383
Brief Title
Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion
Acronym
FISIOPLEURA
Official Title
Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Granollers
Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Diseases, Infection
Keywords
pleural disease, infecTion, chest physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chest Physiotherapy group
Arm Type
Active Comparator
Arm Description
Conventional medical treatment plus Chest Physiotherapy
Arm Title
Control grup
Arm Type
No Intervention
Arm Description
Conventional medical treatment
Intervention Type
Other
Intervention Name(s)
Chest physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in improving lung function
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in resolution of pleural effusion
Description
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.
Time Frame
3 months
Title
Reduce hospital stay
Description
To assess if CP added to medical therapy in patients with infectious pleural effusion decreased hospital stay
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inmaculada Castillo
Organizational Affiliation
Hospital General de Granollers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inmaculada Castillo
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08401
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24698396
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.
Results Reference
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PubMed Identifier
16945266
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.
Results Reference
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PubMed Identifier
20029043
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.
Results Reference
background
PubMed Identifier
19889319
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.
Results Reference
background
PubMed Identifier
16493154
Citation
Light RW. Parapneumonic effusions and empyema. Proc Am Thorac Soc. 2006;3(1):75-80. doi: 10.1513/pats.200510-113JH.
Results Reference
background
PubMed Identifier
11035692
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. Erratum In: Chest 2001 Jan;119(1):319.
Results Reference
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Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion

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