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临床试验/NCT05834608
NCT05834608已完成不适用

Cerebral Regional Oxygenation with Manual Versus Mechanical Ventilator Assisted Ventilation During Intravenous Induction in Pediatric Patients

Marmara University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2022年6月1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
51
试验地点
1
主要终点
NIRS_-1

研究概览

简要总结

Anesthesia induction is associated with hemodynamic imbalances that can affect the blood flow to major organs. Moreover it can result in deoxygenation as well. During standard anesthesia induction the patient is manually ventilated with a circle-valve-mask system until the effect of muscle relaxant shows of. Near-infrared spectroscopy (NIRS) is a modification of a well-known peripheral pulse oxymetry that is used in the detection of the regional oxygen saturation (rSO2) in organs, including brain, liver, muscle, and intestines. In this study we will compare the regional oxygenation status of the patients during anesthesia induction in which either standard manual ventilation or mechanical ventilator-assisted ventilation was performed. AutoFlow(R) mode of Draeger-Perseus mechanical ventilator will be used for the ventilator-assisted ventilation.

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
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anaesthesiologists (ASA) physical status I-II

排除标准

  • ASA III or above
  • Congenital or traumatic brain injury
  • Allergy to NIRS probe material
  • Cardiac or vascular disease, including heart failure or hypertension
  • Difficult mask ventilation and difficult intubation
  • Thoracic surgery
  • Head and neck surgery
  • Emergency surgery

结局指标

主要结局

NIRS_-1

时间窗: 60 seconds before induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_0.5

时间窗: 30 seconds after the anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_1

时间窗: 60 seconds after the anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_1.5

时间窗: 90 seconds after the anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_2

时间窗: 120 seconds after the anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

NIRS_0

时间窗: At the start of anesthesia induction.

Serebral oxygenation status measured by near-infrared spectroscopy device (INVOS oximeter, Somanetics, Troy, MI, USA).

次要结局

未报告次要终点

研究者

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

Ruslan Abdullayev

Assoc. Prof.

Marmara University

研究点 (1)

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