ConsCIOUS2 Study of the Isolated Forearm Technique Commands

University of Wisconsin, Madison344 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

344

Conditions

Anesthesia Awareness

Interventions

IFT Testing1OTHER

Command List A

IFT Testing 2OTHER

Command List B

IFT Testing 3OTHER

Command List C

IFT Testing 4

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-40 years 2. English (or local language) competent 3. Informed consent obtained 4. Patients clinically requiring general anesthesia and intubation 5. Able to safely follow the IFT commands when awake and prior to their operation, per discretion of the PI. Exclusion Criteria: 1. Age \< 18 years old, \>40 years old 2. Unable or unwilling to sign consent 3. Unable to undergo postoperative questions 4. 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.

Locations (11)

Cornell University

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: Intra-operative

Secondary Outcomes

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

Time frame: 15 minutes and 60 minutes after PACU admission

EEG

Collect EEG data to identify monitoring patterns that discriminate responders and non-responders

Time frame: 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

Time frame: 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.

Time frame: 24 hours and 7 days post-op

Predisposing Factors

Chart review of demographic factors that predispose to IFT responsiveness.

Time frame: Pre-operative

Data from ClinicalTrials.gov

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