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临床试验/NCT03742141
NCT03742141已完成不适用

Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

Icahn School of Medicine at Mount Sinai5 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年10月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
5
主要终点
Frequency of Congruence of Nerve Integrity and Vocal Cord Functions

研究概览

简要总结

The purpose of this study is to describe the impact of adding intraoperative video laryngoscopy (IOVL) to intraoperative laryngeal nerve monitoring (IOLNM) during neck procedures when IOLNM is routinely used, including thyroidectomy and re-operative parathyroidectomy. Specifically, the study team seeks to assess how frequently the use of IOVL provided confirmatory or additional information that may affect surgeon decision-making when IOLNM alone is ambiguous, or when there is equipment malfunction or failure. The IOVL is a disposable, otherwise standard fiberoptic laryngoscope (Larynxview, Neurovision Medical, Ventura CA) that is inserted alongside the endotracheal tube following intubation for surgical procedures. It allows assessment of vocal cord movement in response to nerve stimulation. Currently, the use of IOLNM is based on audio cues, and visual assessment of external laryngeal muscle movement during surgery in response to stimulation, but no direct assessment of vocal cord movement is routinely possible. This information can be ambiguous and subject to judgement of the surgeon. The addition of IOVL provides direct assessment to vocal cord movement in response to stimulus, and may be useful in light of ambiguous IOLNM data, or limited visualization of external laryngeal muscles.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Age 18 and older with capacity to make all medical decisions
  • Medical indication for partial or total thyroidectomy, re-operative parathyroidectomy, or neck dissection

排除标准

  • Patients who are under the age of 18
  • Patients who are not able to make medical decisions or consent to research

研究组 & 干预措施

Intraoperative Video Laryngoscopy

Experimental

Participants undergoing neck procedures

干预措施: Intraoperative Video Laryngoscopy (Device)

Intraoperative Video Laryngoscopy

Experimental

Participants undergoing neck procedures

干预措施: Glycopyrrolate (Drug)

结局指标

主要结局

Frequency of Congruence of Nerve Integrity and Vocal Cord Functions

时间窗: up to 3 months post-resection

Frequency of congruence - IOVL used in conjunction with routine intraoperative nerve monitoring to provide additional data on nerve integrity and vocal cord functions for patients undergoing neck procedures that place the recurrent and superior laryngeal nerves at risk for injury or postoperative dysfunction. Video-captured vocal cord movement as well as the Nerveana Power Index (NPI) audio signal were recorded. Loss of signal was considered any NPI value \<100, which corresponds to loss of audio signal. The NPI is specific to the Nerveana machine, and is an index of the nerve/muscle response power (or area under the curve) as a percentage of the threshold level of response. Thus, positive EMG signal (EMG+) was an NPI value \>100. Positive IOVL (IOVL+) correlated with observed vocal cord movement on nerve stimulation; negative IOVL indicated no visible vocal cord movement. Discordances were considered to be contradictory IOVL and EMG (e.g., IOVL+ EMG-) findings for a particular nerve.

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

Randall Owen

Associate Professor

Icahn School of Medicine at Mount Sinai

研究点 (5)

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