ConsCIOUS2 Study of the Isolated Forearm Technique Commands

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

Detailed Description
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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.

Official Title
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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

Conditions
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Anesthesia Awareness

Intervention / Treatment
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* Other: IFT Testing1
* Other: IFT Testing 2
* Other: IFT Testing 3
* Other: IFT Testing 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IFT Testing 1<br>Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness. | Other: IFT Testing1<br>* Command List A<br>* Other names: Command List A;|
| Experimental: IFT Testing 2<br>Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness. | Other: IFT Testing 2<br>* Command List B<br>* Other names: Command List B;|
| Experimental: IFT Testing 3<br>Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness. | Other: IFT Testing 3<br>* Command List C<br>* Other names: Command List C;|
| Experimental: IFT Testing 4<br>Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness. | Other: IFT Testing 4<br>* Command List D<br>* Other names: Command List D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responsiveness | Identify the incidence of IFT responsiveness following intubation assessed by hand squeezing response following a randomized command sequence to assess for non-specific responses. | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Confusion Following Emergence | Test the association between intra-operative IFT responsiveness and patient reported confusion following emergence from anesthesia and objectively assessed confusion using the NuDesc | 15 minutes and 60 minutes after PACU admission | 
| EEG | Collect EEG data to identify monitoring patterns that discriminate responders and non-responders | Intra-operative | 
| Anesthesia Awareness with Recall | Identify the incidence of implicit memory in post anesthesia care unit and anesthesia awareness with recall 24 hours and 7 days postoperatively using the structured Modified Brice questionnaire | 24 hours and 7 days post-op | 
| Anesthesia Satisfaction | Identify changes in patient satisfaction associated with IFT responsiveness via a patient satisfaction questionnaire administered 24 hours and 7 days postoperatively. | 24 hours and 7 days post-op | 
| Predisposing Factors | Chart review of demographic factors that predispose to IFT responsiveness. | Pre-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Consciousness, Electroencephalography, Anesthesia