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ConsCIOUS2 Study of the Isolated Forearm Technique Commands

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Anesthesia Awareness Other: IFT Testing1 Other: IFT Testing 2 Other: IFT Testing 3 Other: IFT Testing 4 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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
Actual Study Start Date : April 4, 2018
Actual Primary Completion Date : December 23, 2019
Actual Study Completion Date : December 23, 2019

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 Name: 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 Name: 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 Name: 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 Name: Command List D




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. EEG [ Time Frame: Intra-operative ]
    Collect EEG data to identify monitoring patterns that discriminate responders and non-responders

  3. 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

  4. 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.

  5. Predisposing Factors [ Time Frame: Pre-operative ]
    Chart review of demographic factors that predispose to IFT responsiveness.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503357


Locations
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United States, New York
Cornell University
New York, New York, United States, 10065
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53703
Australia
Cairns Hospital
Cairns, Australia
Belgium
Centre Hospitalier Regional de la Citadelle
Liège, Belgium
Germany
RWTH Aachen University
Aachen, Germany
University of Munich
Munich, Germany
Israel
Rambam Health Care Campus
Haifa, Israel
Netherlands
University of Groningen
Groningen, Netherlands
New Zealand
Auckland District Health Board
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
University of Wisconsin, Madison
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
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Principal Investigator: Robert Sanders, MBBS, PhD, FRCA University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03503357    
Other Study ID Numbers: 2017-0728
A530900 ( Other Identifier: UW Madison )
SMPH\ANESTHESIOLOGY\ANESTHESIO ( Other Identifier: UW Madison )
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Consciousness
Electroencephalography
Anesthesia
Additional relevant MeSH terms:
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Intraoperative Awareness
Intraoperative Complications
Pathologic Processes