Validation of the Measurement of Respiratory Work Using Diaphragm Electrical Activity in Infant and Children During Weaning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- The correlation between diaphragmatic electrical activity (edi) and the work of breathing assessed by measuring the oesophageal pressure time product (PTP) during mechanical ventilation weaning
研究概览
简要总结
Mechanical ventilation is a vital therapeutic support, widely used in pediatric intensive care. Invasive ventilation (IV) is associated with risk of major complications ( nosocomial pneumonia, secondary pulmonary barotrauma injuries, pneumothorax) , which can increase : the duration of ventilation, mortality, length of ICU stay and health costs. The practitioner should ask the benefit of the continuation of this IV daily and adapting it, to limit complications. The evaluation of the work of breathing is a key element in understanding the pathophysiology of respiratory distress but is also a key element in improving the management of ventilatory support and the adjustment of ventilatory parameters .
It has been shown that there is an increased work of breathing in all children admitted in ICU for clinical acute respiratory distress that is significantly reduced by ventilatory support. There is probably a relationship that should be proportional between the work of breathing ( PTP ) resulting in respiratory request triggered by the respiratory drive and the electrical activity of the diaphragm ( Edi ) .
The validation of this correlation PTP / Edi has a direct impact on the monitoring of ventilated patients with the ability to monitor the physiological factor while maintaining a classical treatment of children by simply monitoring Edi without additional invasive device .
详细描述
It is very important that the respirators detect the child's breathing efforts. This makes it possible to reduce the pressure used by the respirator to push air into the child's lungs, to improve oxygen distribution throughout the child's body and reduce the level of sedation Typical systems do not really detect changes in breathing efforts, but rather volumes of exhaled air. Therefore, the respirator is not always synchronized with patient's respiration and there may be a delay between breathing cycles and the ventilator's, which leads to an increase in his respiratory effort.
Assessing respiratory work is a key element in improving the management of ventilatory support and the adaptation of ventilatory parameters. At this time, routinely used measurements do not include quantitative measurement of the respiratory work, as it requires the installation of probes with pressure heads.
There is new technology known as Neurally Adjusted Ventilatory Assist (NAVA) that employs a probe inserted into the stomach that detects the electrical activity of the diaphragm (primary breathing muscle).The probe is connected to the respirator and triggers respiratory assistance through diaphragm electrical activity, thereby ensuring respiratory assistance that is adapted to the child's needs. This artificial ventilatory mode has already been widely used during invasive ventilation in adults and for short periods of time in infants, children and premature newborn. Health Canada has authorized the use of the NAVA ventilatory mode within the context of this study.
The aim of this study is to assess whether there is a relation between the electrical activity of the diaphragm and respiratory work. This will enable the use of diaphragm activity that can be recorded daily at the child's bedside as an element of respiratory monitoring and allow early detection of dangerously high or low respiratory levels.
The study plans to recruit 20 patients at the CHU Sainte-Justine, which is the only hospital taking part in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Up to 18 years
- •Child on invasive mechanical ventilation for which the withdrawal phase was determined by the clinician in charge of the patient
- •Consent obtained
排除标准
- •Post conceptional age < 37 weeks
- •Contraindication to changing or insertion of nasogastric tube (esophageal malformation, gastrointestinal bleeding, esophageal varices)
- •Curarised patient
结局指标
主要结局
The correlation between diaphragmatic electrical activity (edi) and the work of breathing assessed by measuring the oesophageal pressure time product (PTP) during mechanical ventilation weaning
时间窗: within 12 hours of extubation
次要结局
- Measure of the asynchrony index (AI) during NAVA and standard mode. Comparison of AI and PTP between NAVA and standard mode(within 12 hours of extubation)
- Rate profile of Edi and PTP as a predictor of success or failure of the withdrawal(within 48 hours after extubation)
研究者
Dr Guillaume Emeriaud
MD, PhD
St. Justine's Hospital