跳至主要内容
临床试验/NCT03453294
NCT03453294已完成不适用

Effect of Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) During Apneic Oxygenation in General Anesthesia on Biomarkers

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Oxidative stress

研究概览

简要总结

Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as biological stress response detected by blood-bourne biomarkers before implementing it into clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults, >18 years old.
  • Laryngeal-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
  • Capable of understanding the study information and sign the written consent.

排除标准

  • American Society of Anaesthesiologist severity score >2
  • New York Heart Association score >2
  • Pacemaker or ICD.
  • Body Mass Index >35
  • Manifest cardiac failure or coronary disease
  • Severe gastrointestinal reflux.
  • Neuromuscular disorder

结局指标

主要结局

Oxidative stress

时间窗: Up to 2 hours after start of intervention

Biomarkers of oxidative stress such as Thiobarbituric acid reactive substances, Advanced Oxidation Protein Products,Reactive oxygen species and total antioxidant capacity in blood samples

次要结局

  • Inflammatory response(Up to 2 hours after start of intervention)
  • Biomarkers of cardiac damage(Up to 2 hours after start of intervention)
  • Biomarkers of neuronal injury(Up to 2 hours after start of intervention)
  • Biomarkers of kidney injury(Up to 2 hours after start of intervention)
  • Markers of RNA damage(Up to 2 hours after start of intervention)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Malin Jonsson Fagerlund

Senior Consultant, Associate Professor

Karolinska University Hospital

研究点 (1)

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