ConsCIOUS2 Study of the Isolated Forearm Technique Commands

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia Awareness
• Intervention / Treatment: Other: IFT Testing1; Other: IFT Testing 2; Other: IFT Testing 3; Other: IFT Testing 4

Detailed Description

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
• Enrollment (Actual): 344
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Cairns, Australia
    • Cairns Hospital
• Belgium
  • Liège, Belgium
    • Centre Hospitalier Regional de la Citadelle
• Germany
  • Aachen, Germany
    • RWTH Aachen University
  • Munich, Germany
    • University of Munich
• Israel
  • Haifa, Israel
    • Rambam Health Care Campus
• Netherlands
  • Groningen, Netherlands
    • University of Groningen
• New Zealand
  • Auckland, New Zealand
    • Auckland District Health Board
  • Hamilton, New Zealand
    • Waikato Hospital
• United States
  • New York
    • New York, New York, United States, 10065
      • Cornell University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Wisconsin
    • Madison, Wisconsin, United States, 53703
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Rambam Health Care Campus; University of Pennsylvania; RWTH Aachen University; Ludwig-Maximilians - University of Munich; Cornell University; University of Groningen; Centre Hospitalier Régional de la Citadelle; Auckland District Health Board; Waikato Hospital; Cairns Hospital
• Investigators: Principal Investigator: Robert Sanders, MBBS, PhD, FRCA, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): December 23, 2019

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Anesthesia; Electroencephalography; Consciousness
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Intraoperative Awareness
• Other Study ID Numbers: 2017-0728; A530900 (Other Identifier: UW Madison); SMPH\ANESTHESIOLOGY\ANESTHESIO (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No