Effects of Respiratory Physiotherapy on Pleural Effusion
Primary Purpose
Pleural Effusion
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Respiratory physiotherapy
Conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Effusion focused on measuring Pleural Effusion, Respiratory physiotherapy, Length of stay
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of pleural effusion based on the presence of a consistent radiological finding on simple posteroanterior and lateral chest X-rays, and decubitus lateral in cases of small PE.
Exclusion Criteria:
- Non diagnosis of pleural effusion
Sites / Locations
- Universitary Hospital San Cecilio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Respiratory physiotherapy
Conservative treatment
Arm Description
54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.
49 people were recruited in this group. These participants received conservative medical treatment intervention
Outcomes
Primary Outcome Measures
Assessment of the severity of respiratory disease
A spirometry is used to assess severity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second, and the forced expiratory flow over the middle one half of the forced vital capacity.
Secondary Outcome Measures
Length of the hospital stay
Length of stay was defined as the number of days between admission and discharge.
Severity in the pleural effusion repercussion
The chest radiograph has been the initial diagnostic tool for the detection and evaluation of pleural effusion. The severity was codified from 0(normal) to 10 (very severe) by a radiologist with more than 8 years of experience.
Full Information
NCT ID
NCT01756742
First Posted
December 20, 2012
Last Updated
December 20, 2012
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT01756742
Brief Title
Effects of Respiratory Physiotherapy on Pleural Effusion
Official Title
Effectiveness of a Program of Respiratory Physiotherapy on Pleural Effusion: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pleural effusion and the complexity of diagnosis and treatment make planning and delivering care challenging. Respiratory physiotherapy is recommended, and should be applied during the first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a University Hospital.
Detailed Description
Approximately 1.5 million patients are diagnosed with pleural effusion each year in the United States . Pleural effusion (PE) is an accumulation of fluid in the pleural space that is classified as transudate or exudate according to its composition and underlying pathophysiology. The goal in the management of pleural effusion is to provide symptomatic relief by removing fluid from the pleural space and to allow the treatment of the underlying disease. While some authors (REF) propose respiratory physiotherapy, in the majority of the cases only the medical treatment combined with the pleural fluid removal by thoracentesis are the most common practice. The objective of this study is verify the effectiveness of respiratory physiotherapy in pleural effusion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
Pleural Effusion, Respiratory physiotherapy, Length of stay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respiratory physiotherapy
Arm Type
Experimental
Arm Description
54 people according to the inclusion criteria were recruited to have a respiratory physiotherapy treatment added to their medical intervention.
Arm Title
Conservative treatment
Arm Type
Placebo Comparator
Arm Description
49 people were recruited in this group. These participants received conservative medical treatment intervention
Intervention Type
Other
Intervention Name(s)
Respiratory physiotherapy
Other Intervention Name(s)
Respiratory techniques added to conservative treatment
Intervention Description
The respiratory physiotherapy intervention included:
Mobilisation techniques: limb exercises (passive, active assisted, or active resisted)
Chest physiotherapy: it included a Controlled breathing program, pursed lips breathing (PLB), active expiration and incentive spirometry.
Intervention Type
Other
Intervention Name(s)
Conservative treatment
Other Intervention Name(s)
Medical treatment
Intervention Description
Conservative medical treatment intervention for pleural effusion.
Primary Outcome Measure Information:
Title
Assessment of the severity of respiratory disease
Description
A spirometry is used to assess severity of individual patients respiratory disease and their response to therapy and is regarded as the gold standard measure of respiratory function. The following variables were recorded; forced vital capacity, forced expiratory volume achieved in 1 second, and the forced expiratory flow over the middle one half of the forced vital capacity.
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Length of the hospital stay
Description
Length of stay was defined as the number of days between admission and discharge.
Time Frame
baseline, 12 months
Title
Severity in the pleural effusion repercussion
Description
The chest radiograph has been the initial diagnostic tool for the detection and evaluation of pleural effusion. The severity was codified from 0(normal) to 10 (very severe) by a radiologist with more than 8 years of experience.
Time Frame
baseline, 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of pleural effusion based on the presence of a consistent radiological finding on simple posteroanterior and lateral chest X-rays, and decubitus lateral in cases of small PE.
Exclusion Criteria:
Non diagnosis of pleural effusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Carmen Valenza, MD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary Hospital San Cecilio
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18012
Country
Spain
12. IPD Sharing Statement
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Effects of Respiratory Physiotherapy on Pleural Effusion
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