Back to resultsChest Physiotherapy in Pediatrics Patients With Pneumonia
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physiotherapy
Positioning and cough
Sponsored by
About this trial
This is an interventional supportive care trial for Pneumonia focused on measuring physiotherapy, children, clinical trial
Eligibility Criteria
Inclusion Criteria:
- Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours)
Exclusion Criteria:
- Severely ill patients (hospitalized in intensive care units)
- Pleural effusion treated with chest drainage
- Atelectasis detected by x-ray
- Pneumonia or pleural effusion in the previous six months
- Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency
Sites / Locations
- Santa Casa de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Physiotherapy
Arm Description
Non-mandatory request to maintain lateral positioning to improve air exchange, to cough in order to clear secretion, and to perform diaphragmatic and deep breathing, for five minutes, once a day, during hospital stay.
Physiotherapy: Children younger than 5 years: Manual Thoracic vibration (TV), thoracic compression (TC), positive expiratory pressure (PEP), and forced exhalation with the glottis open ("huffing"). Children aged 5 years or older: same procedures in addition to the ventilatory patterns, and a forced expiratory technique (FET), consisting of one or two "huffs" (forced expirations) followed by a period of relaxed, controlled diaphragmatic breathing, three times per day, for 10 to 12 minutes, during hospital admission.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01017081
First Posted
November 19, 2009
Last Updated
November 19, 2009
Sponsor
Santa Casa de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT01017081
Brief Title
Chest Physiotherapy in Pediatrics Patients With Pneumonia
Official Title
Chest Physiotherapy in Pediatric Patients Hospitalised With Community-acquired Pneumonia: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Santa Casa de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
physiotherapy, children, clinical trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Non-mandatory request to maintain lateral positioning to improve air exchange, to cough in order to clear secretion, and to perform diaphragmatic and deep breathing, for five minutes, once a day, during hospital stay.
Arm Title
Physiotherapy
Arm Type
Experimental
Arm Description
Physiotherapy: Children younger than 5 years: Manual Thoracic vibration (TV), thoracic compression (TC), positive expiratory pressure (PEP), and forced exhalation with the glottis open ("huffing"). Children aged 5 years or older: same procedures in addition to the ventilatory patterns, and a forced expiratory technique (FET), consisting of one or two "huffs" (forced expirations) followed by a period of relaxed, controlled diaphragmatic breathing, three times per day, for 10 to 12 minutes, during hospital admission.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy: three times per day, for 10 to 12 minutes, during hospital admission
Intervention Type
Other
Intervention Name(s)
Positioning and cough
Intervention Description
Non-mandatory request to maintain lateral positioning to improve air exchange and cough
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours)
Exclusion Criteria:
Severely ill patients (hospitalized in intensive care units)
Pleural effusion treated with chest drainage
Atelectasis detected by x-ray
Pneumonia or pleural effusion in the previous six months
Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency
Facility Information:
Facility Name
Santa Casa de Porto Alegre
City
Posto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90020-160
Country
Brazil
12. IPD Sharing Statement
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Chest Physiotherapy in Pediatrics Patients With Pneumonia
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