Continuous Monitoring of Lungs Ventilation Dynamics by Small Surface Patches That Include Safe Mechanical Sensors. A Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 3
- 主要终点
- A data-bank of the recordings obtained at various clinical settings acquired by the sensors
研究概览
简要总结
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. The complications usually develop in a progressive manner, but are currently detected relatively late, when there is already severe and life threatening deterioration in patient oxygenation and sometimes irreversible damages.
Objective:To measure chest wall dynamics, derived from sensors placed on the chest and abdomen.
Methods: The system comprises of patches attached to the chest wall and upper abdomen that include mechanical sensors that measure the mechanics of lung inflation and deflation.
详细描述
Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further life threatening deterioration following the development of mechanical problems related to airway management, development of lung barotrauma or displacement of the endotracheal tube.
Neonates especially need tight and sensitive monitoring of lung ventilation, because of the high prevalence of lung disease and need for ventilatory support in this population.
Methods:
The system comprises of patches attached to the chest wall and to the epigastrium. The patches include sensors that measure the mechanics of the lung inflation and deflation.
Study protocol
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants that require tight monitoring of lung ventilation.
- •Parents that understand and read Hebrew or Russian or Arabic.
排除标准
- •Parental refusal to participate in the study.
- •Premature babies under 700 grams.
- •Prematurity below 26 weeks gestation.
- •Severe edematous babies (Hydrops fetalis).
- •Severe Hypoxic Ischemic Encephalopathy, initial brain injury or severe intracranial bleeding.
- •Skin reactions to the adhesive patches.
结局指标
主要结局
A data-bank of the recordings obtained at various clinical settings acquired by the sensors
时间窗: one year
次要结局
- Establishment of a novel data bank that includes clinical cases of changes in ventilation and the comparison between the different monitored parameters.(one year)