- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07722364
HFCWO in Children With Non-CF Bronchiectasis
Effect of High Frequency Chest Wall Oscillation on Pulmonary Functions in Children With Non-Cystic Fibrosis Bronchiectasis
Study Overview
Status
Conditions
Detailed Description
The purpose of this study is to evaluate the effect of using HFCWO intervention on pulmonary functions in children with bronchiectasis.
it hypothesized that Using HFCWO has no effect on pulmonary functions and hospital stay in children with bronchiectasis.
Children subjected to the inclusion criteria will be assigned randomly into two groups, control group and study group.
Does high frequency chest wall oscillation (HFCWO) have an effect in pulmonary functions in children with bronchiectasis? RCT study Control group Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
Study group This group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group.
The frequency of treatment will be 5 sessions/week for three successive months for both groups for long term effect and daily for immediate effect.
outcome measure: FEV1, FVC, FEV1/FVC quality of life for bronchiectasis, 6-minute walk test
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marwa elkawy, Msc
- Phone Number: 01030077626
- Email: marwa.elkawy@sphinx.edu.eg
Study Locations
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Asyut, Egypt
- pediatric hospital, Assiut university
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Contact:
- Marwa elkawy, Msc
- Phone Number: 01030077626
- Email: marwa.elkawy2018@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Children with no cystic fibrosis bronchiectasis
- Both sexes
- Their ages ranges from 6-12 years
- After 48 hours of attack, if hemoptysis or fever not found
Exclusion Criteria:
• Osteoporosis (Calcium deficiency)
- Bleeding tendency
- Recent surgery of brain, eye, thoracic, or neck surgery
- Pneumothorax
- Cystic fibrosis bronchiectasis
- Pulmonary embolism
- Rib fracture
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional progr
This group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group. The frequency of treatment will be 5 sessions/week for three successive months for both groups for long term effect and daily for immediate effect. |
High-frequency chest wall oscillation that applies external chest wall oscillations via an inflatable vest worn around the thoracic cage, increasing the air-liquid shear forces during expiration is believed to result in secretion mobilization. The product name that will be used is Air Way Clearness system; his model is PV-900/ PV-300/PV-100, made in China. |
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Active Comparator: children who will be treated by conventional physiotherapy program
Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
|
conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. Conventional physiotherapy that will be applied to the control group for 30 minutes will include:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Baseline and after 8 weeks of treatment
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Change in FEV1 measured by spirometry according to ATS/ERS guidelines
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Baseline and after 8 weeks of treatment
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Forced Vital Capacity (FVC)
Time Frame: Baseline and after 6 months of treatment
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Change in FVC measured by spirometry according to ATS/ERS guidelines
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Baseline and after 6 months of treatment
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FEV1/FVC Ratio
Time Frame: Baseline and after 6 months of treatment
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Change in FEV1/FVC ratio measured by spirometry according to ATS/ERS guidelines
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Baseline and after 6 months of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-Minute Walk Distance (6MWD)
Time Frame: Baseline and after 6 months of treatment
|
hange in functional exercise capacity assessed by the Six-Minute Walk Test (6MWT).
The total distance walked in six minutes is recorded according to the American Thoracic Society (ATS) guidelines.
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Baseline and after 6 months of treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Genetic Diseases, Inborn
- Respiratory Tract Diseases
- Digestive System Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Bronchial Diseases
- Pancreatic Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Cystic Fibrosis
- Bronchiectasis
- Therapeutics
- Public Health
- Environment and Public Health
- Health Status
- Demography
- Epidemiologic Measurements
- Respiratory Therapy
- Quality of Life
- Chest Wall Oscillation
Other Study ID Numbers
- HFCWO and bronchectasis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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