Position of Laryngeal Mask in Paediatric Patients During Magnetic Resonance Imaging: Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Displacement of the laryngeal mask on the MRI imaging
研究概览
简要总结
The aim of the trial is to obtain and to describe the position of the laryngeal mask during elective magnetic resonance imaging in paediatric patient. The radiologic findings will be compared to the clinical performance of the laryngeal mask.
详细描述
Properly inserted laryngeal mask (LMA) with good clinical performance can be misplaced (on radiological imaging) but with not know effect on clinical practice. The percentage of the misplaced LMAs are relatively high, but the exact number in paediatric population is currently not clear. The aim of this prospective observational cohort study is to describe the percentage of misplaced LMAs during elective magnetic resonance imaging (MRI) in paediatric patient. After approval of the local ethical committee all elective paediatric patients in study interval (10/2016-3/2017) indicated for elective MRI of the brain or elective MRI of the brain and cervical spine will be included to the trial. Demographic characteristics - age, weight, comorbidities, anesthesia management - education of anesthesiologist, type of LMA, number of insertion attempts, clinical performance of the LMA, presence/absence of leak, the peak inspiratory pressure (mechanical ventilation), volume of air in cuff, complications during anesthesia and LMA soil after extraction - blood, saliva, mucus, gastric content. The clinical performance will be compared to the LMA position on MRI - position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae, displacement of the epiglottis, distance between proximal LMA cuff and vocal cords, distance between distal LMA cuff and vocal cords.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •paediatric patient undergoing elective MRI scanning - brain and/or brain and cervical spine
- •laryngeal mask inserted for airway management during anesthesia
- •age between 29 days and 19 years
排除标准
- •outside the age limit
- •laryngeal mask contraindication - gastroesophageal reflux disease, ileus, full stomach, impairment of the haemodynamics
结局指标
主要结局
Displacement of the laryngeal mask on the MRI imaging
时间窗: 6 months
position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae distance between proximal LMA cuff and vocal cords
次要结局
- Clinical performance of the LMA(6 months)
- Demographic characteristics(6 months)
研究者
Petr Štourač, MD
doc.MD.Ph.D
Brno University Hospital
