Effects of Non-invasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) on Ventilation Distribution, Measured by Electrical Impedance Tomography (EIT), During Deep Sedation in Paediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Regional Ventilation Delay (pixels %), RDV
研究概览
简要总结
In patients undergoing spontaneous breathing (SB) deep sedation there is a re-distribution of ventilation towards lungs non-dependant areas (ventral areas in supine position).
Non-invasive ventilation (NIV), offering positive pressure, should favour a better ventilation of dependant areas (dorsal areas in supine position), making ventilation more homogeneous and increasing functional residual capacity.
Electrical impedance tomography (EIT) is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable; it allows to study ventilation distribution, and it can measure and calculate also parameters that are related to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as anaesthesia or PEEP-application.
Uses of EIT in paediatric age are described in literature, but it has never been described as being used in Non-Operating Room Anaesthesia, nor in other cases of SB deep sedation. In addition, the impact of NIV on the distribution of ventilation in healthy paediatric patients undergoing deep sedation has never been described.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric age (from 1 to 10 years old)
- •ASA score ≤ 2
- •Sedation time ≥ 30 min
排除标准
- •ASA score ≥ 3
- •Lung pathologies (such as asthma, bronchopulmonary dysplasia, obstructive sleep apnoea) Preterm infant
- •Severe obesity
- •Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis)
- •Neuromuscular, mitochondrial, metabolic or chromosomal disease with hypotonia
- •CPAP or NIV treatment at home
- •Hand-Bag Ventilation (HBV) during the procedure (loss of the respiratory drive)
- •Non-Total IntraVenous Anaesthesia (TIVA), adherence to the sedation protocol
- •Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator)
结局指标
主要结局
Regional Ventilation Delay (pixels %), RDV
时间窗: 1 day
It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation
次要结局
- Gravity Centre(pixels %), GC(1 day)
- Inhomogeneity Index (pixels), GI(1 day)