ConsCIOUS2 Study of the Isolated Forearm Technique Commands

• ClinicalTrials.gov Identifier: NCT03503357
• Recruitment Status: Completed
• First Posted: April 19, 2018
• Last Update Posted: January 18, 2020
• Sponsor: University of Wisconsin, Madison
• Collaborators: Rambam Health Care Campus; University of Groningen; Centre Hospitalier Regional de la Citadelle; RWTH Aachen University; University of Pennsylvania; Ludwig-Maximilians - University of Munich; Cornell University; Cairns Hospital; Auckland District Health Board; Waikato Hospital
• Information provided by (Responsible Party): University of Wisconsin, Madison

Tracking Information

• First Submitted Date: March 27, 2018
• First Posted Date: April 19, 2018
• Last Update Posted Date: January 18, 2020
• Actual Study Start Date: April 4, 2018
• Actual Primary Completion Date: December 23, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2018)

Responsiveness [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 18, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ConsCIOUS2 Study of the Isolated Forearm Technique Commands
• Official Title: 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
• Brief Summary: ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test (IFT) responder while under anesthetic.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Basic Science
• Condition: Anesthesia Awareness

Intervention

• Other: IFT Testing1
  Command List A
  Other Name: Command List A
• Other: IFT Testing 2
  Command List B
  Other Name: Command List B
• Other: IFT Testing 3
  Command List C
  Other Name: Command List C
• Other: IFT Testing 4
  Command List D
  Other Name: Command List D

Study Arms

• Experimental: IFT Testing 1
  Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness.
  Intervention: Other: IFT Testing1
• Experimental: IFT Testing 2
  Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness.
  Intervention: Other: IFT Testing 2
• Experimental: IFT Testing 3
  Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness.
  Intervention: Other: IFT Testing 3
• Experimental: IFT Testing 4
  Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness.
  Intervention: Other: IFT Testing 4

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 14, 2020): 333
• Original Estimated Enrollment (submitted: April 18, 2018): 500
• Actual Study Completion Date: December 23, 2019
• Actual Primary Completion Date: December 23, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Germany, Israel, Netherlands, New Zealand, United States

Administrative Information

• NCT Number: NCT03503357
• Other Study ID Numbers: 2017-0728; A530900 ( Other Identifier: UW Madison ); SMPH\ANESTHESIOLOGY\ANESTHESIO ( Other Identifier: UW Madison )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Wisconsin, Madison
• Study Sponsor: University of Wisconsin, Madison

Collaborators

• Rambam Health Care Campus
• University of Groningen
• Centre Hospitalier Regional de la Citadelle
• RWTH Aachen University
• University of Pennsylvania
• Ludwig-Maximilians - University of Munich
• Cornell University
• Cairns Hospital
• Auckland District Health Board
• Waikato Hospital

Investigators

• Principal Investigator: Robert Sanders, MBBS, PhD, FRCA; University of Wisconsin, Madison

• PRS Account: University of Wisconsin, Madison
• Verification Date: January 2020