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ConsCIOUS2 Study of the Isolated Forearm Technique Commands

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ClinicalTrials.gov Identifier: NCT03503357
Recruitment Status : Completed
First Posted : April 19, 2018
Last Update Posted : January 18, 2020
Sponsor:
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  ICMJE March 27, 2018
First Posted Date  ICMJE April 19, 2018
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE April 4, 2018
Actual Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ConsCIOUS2 Study of the Isolated Forearm Technique Commands
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Anesthesia Awareness
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
333
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2018)
500
Actual Study Completion Date  ICMJE December 23, 2019
Actual Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Germany,   Israel,   Netherlands,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03503357
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Robert Sanders, MBBS, PhD, FRCA University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP