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临床试验/NCT04507581
NCT04507581已完成不适用

Evaluation of Atelectasis Formation With Electrical Impedance Tomography During Anesthesia for MRI in Children

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Changes in poorly ventilated lung areas at 2 Hours after intervention

研究概览

简要总结

This study investigates under controlled conditions the variation of poorly ventilated lung units (silent spaces) in children between 1 and 6 years of age measured by electrical impedance tomography during intravenous anaesthesia in a day-hospital setting and before discharge to help further raise safety standards in paediatric anaesthesia

详细描述

Eligible, children, with parental written informed consent, scheduled for a cerebral magnetic resonance image (MRI) will receive an intravenous anaesthesia using a Propofol infusion of 10 mg/kg/h. At the Bern Children's Hospital all children will be premedicated with Midazolam rectal/oral 0.5 mg/kg or Dexmedetomidine nasal 2 mcg/kg 20 minutes before the beginning of the procedure Eligible children will be prepared for procedure according to the local SOPs of the paediatric anaesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP. An iv-line for drugs injection will be placed.

Induction of anaesthesia: after iv-line placement a bolus of Propofol of 2 mg/kg followed by a continuous infusion of 10 mg/kg/h will be applied. Administration of low-flow oxygen for all children (0.3 l/kg/min) via Microstream® Smart CapnoLine® paediatric cannula (Philips Healthcare, Amsterdam, Netherlands). This cannula allows to measure the etCO2.

In case of extremely agitated child an inhalative induction may be performed. This technique represent the actual standard of care and is not associated with increased risks because of the study.

Before induction of the anaesthesia, before the radiological procedure when the induction is terminated, after the termination of the radiological procedure, before transport to the Post anaesthesia Care Unite (PACU), and before the discharge from the PACU after 2 hours of monitoring ventilation distribution changes by thoracic electrical impedance tomography are measured (each measurement will last 1 min).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status 1 to 3,
  • 1 to 6 years of age with legal guardians providing written informed consent.

排除标准

  • Exclusion criteria are necessity to intubate the child,
  • contraindication for propofol administration,
  • congenital heart or lung disease with oxygen
  • dependency and high aspiration risk (requiring rapid sequence induction intubation).

结局指标

主要结局

Changes in poorly ventilated lung areas at 2 Hours after intervention

时间窗: 2 hours

Changes in poorly ventilated lung areas (silent spaces) by using electrical impedance tomography (EIT) 2 hours after the end of anaesthesia before discharge at home, which will help quantify the degree of atelectasis

次要结局

  • Duration of anaesthesia(minutes)
  • 2 minutes after the end of anaesthesia(2 minutes after the end of anaesthesia, before the transport in Post Anaesthesia Care Unit)
  • 2 min after Anesthesia induction(2 minutes after the end of anaesthesia induction)
  • end of the radiological procedure.(2 minutes after the end of radiological procedure)
  • Duration of radiological procedure.(minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Riva

Prof. Dr. med.

Insel Gruppe AG, University Hospital Bern

研究点 (2)

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