Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of oxygen saturation
研究概览
简要总结
Statement of the problem:
•Is there an effect of the cough assist device on Hemodynamic status and oxygen saturation for ventilated children? Null hypothesis There will be no effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children.
详细描述
Subjects:
The study targets the children from both sexes.diagnosed with pneumonia in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study.
Study design:
Randomized controlled clinical trial. Children will receive intervention type randomly,25 child will receive traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.and the other 25 child will receive cough assist device in addition to traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.
Children will be assessed by measuring heart rate, respiratory rate, blood pressure which reflect the physiological status, oxygen saturation,expired Tidal Volume and dynamic lung compliance which reflect clinical improvement of chest condition before and after receiving intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both sexes, with age ranged from 4-9 years old.
- •Children will diagnosed with pneumonia.
- •Children will intubated on mechanical ventilation.
- •All children should be vitally stable during the study period.
- •Exclusion criteria:
排除标准
- •Hemodynamically unstable child.
- •Child with diaphragmatic hernia.
- •Child with pneumothorax (if chest tube is present).
- •Child with raised intracranial pressure.
- •Child with recent upper Gastrointestinal surgery
结局指标
主要结局
Assessment of oxygen saturation
时间窗: 14 days for each participant or time of weaning
Pulse oximeter attached to the child and recorded oxygen saturation before and after intervention.
Assessment of expired Tidal Volume
时间窗: 14 days for each participant or time of weaning
Expired Tidal volume recorded from mechanical ventilation attached to the child before and after intervention
次要结局
未报告次要终点
研究者
Nour Reda Abdelmonem Hafez
Principal investigator
Cairo University