Anesthesia AwarenessNCT03503357
ConsCIOUS2 Study of the Isolated Forearm Technique Commands
A study testing IFT Testing1, IFT Testing 2 and IFT Testing 3 in people with Anesthesia Awareness, run by University of Wisconsin, Madison at 11 sites in 7 countries.
Trial summary
ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test (IFT) responder while under anesthetic. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Awareness
- What is being tested?
- IFT Testing1, IFT Testing 2 and IFT Testing 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 11 sitesin 7 countries
- Study dates
- 4 Apr 2018to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
United States3 sites
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53703
Cornell University
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
New Zealand2 sites
Auckland District Health Board
Auckland
Waikato Hospital
Hamilton
About this study
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
ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test (IFT) responder while under anesthetic.
Read the 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.
- Conditions
- Anesthesia Awareness
- Being tested
- IFT Testing1, IFT Testing 2, IFT Testing 3, IFT Testing 4
- Keywords
- Consciousness, Electroencephalography, Anesthesia
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFT Testing1Other
Also called Command List A
Command List A
IFT Testing 2Other
Also called Command List B
Command List B
IFT Testing 3Other
Also called Command List C
Command List C
IFT Testing 4Other
Also called Command List D
Command List D
| Study group | Role | What they receive |
|---|---|---|
| IFT Testing 1 | Experimental | Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness. Receives: Other: IFT Testing1 |
| IFT Testing 2 | Experimental | Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness. Receives: Other: IFT Testing 2 |
| IFT Testing 3 | Experimental | Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness. Receives: Other: IFT Testing 3 |
| IFT Testing 4 | Experimental | Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness. Receives: Other: IFT Testing 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsiveness
Identify the incidence of IFT responsiveness following intubation assessed by hand squeezing response following a randomized command sequence to assess for non-specific responses.
Measured: Intra-operative
Secondary outcomes (5)
Patient Reported Confusion Following Emergence
Test the association between intra-operative IFT responsiveness and patient reported confusion following emergence from anesthesia and objectively assessed confusion using the NuDesc
Measured: 15 minutes and 60 minutes after PACU admission
EEG
Collect EEG data to identify monitoring patterns that discriminate responders and non-responders
Measured: Intra-operative
Anesthesia Awareness with Recall
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
Measured: 24 hours and 7 days post-op
Anesthesia Satisfaction
Identify changes in patient satisfaction associated with IFT responsiveness via a patient satisfaction questionnaire administered 24 hours and 7 days postoperatively.
Measured: 24 hours and 7 days post-op
Predisposing Factors
Chart review of demographic factors that predispose to IFT responsiveness.
Measured: Pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start4 Apr 2018
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Rambam Health Care Campus, University of Groningen, Centre Hospitalier Régional de la Citadelle, RWTH Aachen University, University of Pennsylvania, Ludwig-Maximilians - University of Munich, Cornell University, Cairns Hospital, Auckland District Health Board, Waikato Hospital
- Responsible party
- Sponsor
- Investigators
- Robert Sanders, MBBS, PhD, FRCA, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503357
- Sponsor's protocol ID
- 2017-0728
- Other IDs
- A530900, SMPH\ANESTHESIOLOGY\ANESTHESIO
- Status last verified
- Dec 2021
- First submitted
- 27 Mar 2018
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03503357
- Acronym / sponsor ID
- 2017-0728
- Conditions
- Anesthesia Awareness
- Keywords
- Consciousness, Electroencephalography, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Rambam Health Care Campus, University of Groningen, Centre Hospitalier Régional de la Citadelle, RWTH Aachen University, University of Pennsylvania, Ludwig-Maximilians - University of Munich, Cornell University, Cairns Hospital, Auckland District Health Board, Waikato Hospital
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IFT Testing 1 | Experimental | Other: IFT Testing1Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness. |
| IFT Testing 2 | Experimental | Other: IFT Testing 2Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness. |
| IFT Testing 3 | Experimental | Other: IFT Testing 3Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness. |
| IFT Testing 4 | Experimental | Other: IFT Testing 4Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFT Testing1Also: Command List ACommand List A | Other | IFT Testing 1 |
| IFT Testing 2Also: Command List BCommand List B | Other | IFT Testing 2 |
| IFT Testing 3Also: Command List CCommand List C | Other | IFT Testing 3 |
| IFT Testing 4Also: Command List DCommand List D | Other | IFT Testing 4 |
Primary outcome
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.
5 secondary outcomes
Patient Reported Confusion Following Emergence
Time frame: 15 minutes and 60 minutes after PACU admission
EEG
Time frame: Intra-operative
Anesthesia Awareness with Recall
Time frame: 24 hours and 7 days post-op
Anesthesia Satisfaction
Time frame: 24 hours and 7 days post-op
Predisposing Factors
Time frame: Pre-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Sanders, MBBS, PhD, FRCA principal investigator
University of Wisconsin, Madison
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IFT Testing1, IFT Testing 2 and IFT Testing 3 in people with Anesthesia Awareness, run by University of Wisconsin, Madison at 11 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Germany, New Zealand, Australia, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responsiveness (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.