HFCWO in Children With Non-CF Bronchiectasis

Официальное название

Effect of High Frequency Chest Wall Oscillation on Pulmonary Functions in Children With Non-Cystic Fibrosis Bronchiectasis

Обзор

the study will concentrate on the effect of High Frequency Chest Wall Oscillation compared to conventional pulmonary physiotherapy on children with non cystic fibrosis bronchiectasis

Подробное описание

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

Вмешательства

• Устройство High Frequency Chest Wall Oscillation
  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.
• Другое 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: * Postural drainage according to accumulation of secretions for 10 minutes accompanied by percussion or vibration * Active cycle breathing technique (ACBT) for 10 minutes * Respiratory exercises for 10 minutes

Первичные конечные точки

• Forced Expiratory Volume in 1 second (FEV1) [Срок оценки: Baseline and after 8 weeks of treatment]
• Forced Vital Capacity (FVC) [Срок оценки: Baseline and after 6 months of treatment]
• FEV1/FVC Ratio [Срок оценки: Baseline and after 6 months of treatment]

Вторичные конечные точки (1)

• Six-Minute Walk Distance (6MWD) [Срок оценки: Baseline and after 6 months of treatment]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• • Osteoporosis (Calcium deficiency)

• Bleeding tendency
• Recent surgery of brain, eye, thoracic, or neck surgery
• Pneumothorax
• Cystic fibrosis bronchiectasis
• Pulmonary embolism
• Rib fracture

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• pediatric hospital, Assiut university — Asyut

Идентификаторы

NCT: NCT07722364 · HFCWO and bronchectasis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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