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临床试验/NCT03567031
NCT03567031已完成不适用

Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
NIRS variation

研究概览

简要总结

The study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia.

详细描述

The study aims at assessing cerebral blood flow (measured with Near-Infrared Reflectance Spectroscopy - NIRS - and transcranial Doppler - DTC) variations following end-tidal expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia performed according to standards of care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

Patient is under general anesthesia

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age < or = 6 months
  • ASA class < or = 3
  • General anesthesia required for surgery

排除标准

  • No parental consent
  • Emergency surgery
  • Preexisting neurological condition
  • Hemodynamic instability
  • Preexisting hypoxemia and/or hypercapnia
  • Laparoscopy or thoracoscopy, if expected EtCO2 level achieving would require unsafe ventilation parameters

研究组 & 干预措施

Main Arm

Experimental

In each patient, under ongoing standard general anesthesia in a stable state, EtCO2 is manually modified to reach predefined values, and after waiting until cerebral blood flow has reached steady state, NIRS and DTC values are noted.

干预措施: EtCO2 modification (Procedure)

结局指标

主要结局

NIRS variation

时间窗: 5 to 10 minutes

Near-Infrared Spectroscopy value variation after EtCO2 modification

次要结局

  • DTC variation(5 to 10 minutes)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Greff

Principal Investigator

St. Justine's Hospital

研究点 (2)

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