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
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
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
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
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
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)
