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Completed

NCT Number: NCT03503357

ConsCIOUS2 Study of the Isolated Forearm Technique Commands

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairns Hospital, Cairns, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-40 years
  • English (or local language) competent
  • Informed consent obtained
  • Patients clinically requiring general anesthesia and intubation
  • Able to safely follow the IFT commands when awake and prior to their operation, per discretion of the PI.

Exclusion criteria

  • Age < 18 years old, >40 years old
  • Unable or unwilling to sign consent
  • Unable to undergo postoperative questions
  • 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.

Treatment and study plan

IFT Testing1

Other

Command List A

Other names: Command List A

IFT Testing 2

Other

Command List B

Other names: Command List B

IFT Testing 3

Other

Command List C

Other names: Command List C

IFT Testing 4

Other

Command List D

Other names: Command List D

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2018
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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