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临床试验/NCT05964166
NCT05964166已完成不适用

Tetragraph® Monitor: Tolerance of Preoperative Placement

Joseph D. Tobias2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年5月31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
42
试验地点
2
主要终点
Tolerance to Preop Placement as Assessed by Likert Scale

研究概览

简要总结

This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.

研究设计

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

入排标准

年龄范围
3 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients requiring anesthetic care and use of neuromuscular blockade
  • Age ≤ 12 years

排除标准

  • History of a peripheral neurologic or neuropathic disorder
  • Upper extremity cannot be used for TOF monitoring
  • Undergoing a surgical procedure in which neuromuscular blockade is not required
  • Patient is edematous
  • Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor

结局指标

主要结局

Tolerance to Preop Placement as Assessed by Likert Scale

时间窗: 30 mins. prior to surgery

Patient's tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by using a 10-point Likert scale with 0=very badly/pulled sensor off and 10=very well/left sensor alone.

次要结局

  • Application Ease(30 minutes prior to surgery)

研究者

发起方
Joseph D. Tobias
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Joseph D. Tobias

Chief of Anesthesiology & Pain Medicine

Nationwide Children's Hospital

研究点 (2)

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