Respiratory Muscles and Work of Breathing in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Esophageal pressure-time product (PTPoes)
研究概览
简要总结
Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.
The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.
详细描述
Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.
Respiratory muscle testing by means of esogastric measurements may allow assessing the effect of pharmacological treatment by comparing respiratory muscle strength before and after a few months with treatment. Moreover, esogastric measurements can be used to better adapt mechanical ventilation or to determine the possibility of weaning from the respiratory support.
The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged less than 18 years old with primary or secondary impairment of respiratory muscles and followed at Necker Hospital
- •Patients under spontaneous breathing or noninvasive or invasive mechanical ventilation
- •Written informed consent
排除标准
- •No social insurance
- •Significant psychomotor retardation
- •Absence of cooperation
- •Significant agitation
- •Hemodynamic instability
- •Acute condition or temporary drug treatments that may interfere with the results of the respiratory muscle explorations
研究组 & 干预措施
Respiratory muscle impairment
Minor patients with primary or secondary impairment of respiratory muscles and followed at Necker Hospital
干预措施: Esogastric pressure measurement (Other)
结局指标
主要结局
Esophageal pressure-time product (PTPoes)
时间窗: Day 0
The integral of the esophageal pressure signal over inspiratory time
Diaphragmatic pressure-time product (PTPdi)
时间窗: Day 0
The integral of the transdiaphragmatic pressure signal over inspiratory time
Work of breathing (WOB)
时间窗: Day 0
Total work of breathing (WOBt) is calculated (in Joules/L) as the area under the pressure-volume curve, using the Campbell diagram. Elastic (WOBe) and resistive (WOBr) are estimated as the 2/3 and 1/3 of WOBt value, respectively.
次要结局
- Maximal sniff pressure(Day 0)
- Esophageal pressure during sniff(Day 0)
- Transdiaphragmatic pressure during sniff(Day 0)
- Diaphragmatic tension-time index(Day 0)
- Vital capacity(Day 0)
- Maximal respiratory static pressures(Day 0)
- Maximal whistle pressure(Day 0)
- Peak expiratory flow(Day 0)
- Twitch transdiaphragmatic pressure(Day 0)
- Measurement of the esophageal pressure during a sniff before and after pharmacological treatment(6 months and 1 year after treatment initiation)
- Adaptation of the respiratory support according to the esophageal pressure-time product values(Day 0)
- Measurement of the esophageal pressure-time product in patients with weaning success and in patients with weaning failure(Day 0)
- Gastric pressure during sniff(Day 0)
- Gastric pressure during cough(Day 0)
- Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the disease severity(Day 0)
- Measurement of esophageal pressure during a sniff in patients with any treatment and patients with no treatment(Day 0)
- Measurement of the esophageal pressure-time product before and after pharmacological treatment(6 months and 1 year after treatment initiation)
- Adaptation of the respiratory support according to the total work of breathing values(Day 0)
- Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with the gas exchange during weaning trial(Day 0)
- Peak cough flow(Day 0)
- Crying transdiaphragmatic pressure(Day 0)
- The total work of breathing before and after pharmacological treatment(6 months and 1 year after treatment initiation)
- Measurement of the total work of breathing in patients with weaning success and in patients with weaning failure(Day 0)
- Inspiratory muscles tension-time index(Day 0)
- Correlation between the pressure-time product, the work of breathing and the respiratory muscle strength with polysomnography and gas exchange results(Day 0)
- Esophageal pressure-time products in patients with any treatment and in patients with no treatment(Day 0)
- The total work of breathing in patients with any treatment and in patients with no treatment(Day 0)
- Measurement of the esophageal pressure during a sniff in patients with weaning success and in patients with weaning failure(Day 0)
- Measurement of transdiaphragmatic pressure during a sniff before and after pharmacological treatment(6 months and 1 year after treatment initiation)