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临床试验/NCT03503357
NCT03503357已完成不适用

ConsCIOUS2: A Prospective Study of the Isolated Forearm Technique Commands, Long-term Sequelae and Electroencephalograph Correlates Following Laryngoscopy and Intubation in Patients 18 - 40 Years of Age

University of Wisconsin, Madison11 个研究点 分布在 7 个国家目标入组 344 人开始时间: 2018年4月4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
入组人数
344
试验地点
11
主要终点
Responsiveness

研究概览

简要总结

ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test (IFT) responder while under anesthetic.

详细描述

500 participants between the ages of 18-40 who will be undergoing surgery requiring general anesthetic will be recruited for this study. This study will use the Isolated Forearm Test (IFT) to identify patients at risk of anesthesia awareness. In the IFT, induction of anesthesia is followed by inflation of a cuff on the dominant arm before neuromuscular blockade (paralysis) is induced. The cuff prevents paralysis of the hand allowing the patient to communicate to an observer through predefined hand movements, typically following a command like: "Mrs. Jones, if you can hear me, squeeze my hand". Participants will thus be asked to follow a series of commands intraoperatively to assess awareness.

Routinely recorded clinical data will be collected to frame the observations about IFT responsiveness, and non-invasive EEG data will also be collected to provide information about the "brain state" of the patients. Patient reported confusion and objectively measured confusion using the Nurse Based Delirium Screening Tool (NuDesc) will be collected post operatively. Finally, participants will be contacted 24 hours and 7 days following their operation to complete an anesthesia satisfaction questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18-40 years
  • •English (or local language) competent
  • •Informed consent obtained
  • •Patients clinically requiring general anesthesia and intubation
  • •Able to safely follow the IFT commands when awake and prior to their operation, per discretion of the PI.

排除标准

  • •Age < 18 years old, >40 years old
  • •Unable or unwilling to sign consent
  • •Unable to undergo postoperative questions
  • •Contraindication to IFT test such as unable to have tourniquet on arm for the IFT (e.g. lymphedema or operative site), rapid sequence inductions and requiring paralysis for laryngoscopy and intubation, per discretion of the PI.

研究组 & 干预措施

IFT Testing 1

Experimental

Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness.

干预措施: IFT Testing1 (Other)

IFT Testing 2

Experimental

Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness.

干预措施: IFT Testing 2 (Other)

IFT Testing 3

Experimental

Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness.

干预措施: IFT Testing 3 (Other)

IFT Testing 4

Experimental

Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness.

干预措施: IFT Testing 4 (Other)

结局指标

主要结局

Responsiveness

时间窗: Intra-operative

Identify the incidence of IFT responsiveness following intubation assessed by hand squeezing response following a randomized command sequence to assess for non-specific responses.

次要结局

  • Predisposing Factors(Pre-operative)
  • Patient Reported Confusion Following Emergence(15 minutes and 60 minutes after PACU admission)
  • Anesthesia Awareness with Recall(24 hours and 7 days post-op)
  • EEG(Intra-operative)
  • Anesthesia Satisfaction(24 hours and 7 days post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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