ConsCIOUS2 Study of the Isolated Forearm Technique Commands
NCT ID: NCT03503357
Last Updated: 2021-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
344 participants
INTERVENTIONAL
2018-04-04
2019-12-23
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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IFT Testing 1
Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness.
IFT Testing1
Command List A
IFT Testing 2
Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness.
IFT Testing 2
Command List B
IFT Testing 3
Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness.
IFT Testing 3
Command List C
IFT Testing 4
Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness.
IFT Testing 4
Command List D
Interventions
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IFT Testing1
Command List A
IFT Testing 2
Command List B
IFT Testing 3
Command List C
IFT Testing 4
Command List D
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
40 Years
ALL
Yes
Sponsors
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Rambam Health Care Campus
OTHER
University of Groningen
OTHER
Centre Hospitalier Regional de la Citadelle
UNKNOWN
RWTH Aachen University
OTHER
University of Pennsylvania
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Cornell University
OTHER
Cairns Hospital
UNKNOWN
Auckland District Health Board
OTHER_GOV
Waikato Hospital
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Robert Sanders, MBBS, PhD, FRCA
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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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
Cairns Hospital
Cairns, , Australia
Centre Hospitalier Regional de la Citadelle
Liège, , Belgium
RWTH Aachen University
Aachen, , Germany
University of Munich
Munich, , Germany
Rambam Health Care Campus
Haifa, , Israel
University of Groningen
Groningen, , Netherlands
Auckland District Health Board
Auckland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Countries
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Other Identifiers
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A530900
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\ANESTHESIOLOGY\ANESTHESIO
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0728
Identifier Type: -
Identifier Source: org_study_id