Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03503357




Registration number
NCT03503357
Ethics application status
Date submitted
27/03/2018
Date registered
19/04/2018
Date last updated
3/12/2021

Titles & IDs
Public title
ConsCIOUS2 Study of the Isolated Forearm Technique Commands
Scientific 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
Secondary ID [1] 0 0
A530900
Secondary ID [2] 0 0
2017-0728
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anesthesia Awareness 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery
Anaesthesiology 0 0 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - IFT Testing1
Other interventions - IFT Testing 2
Other interventions - IFT Testing 3
Other interventions - IFT Testing 4

Experimental: IFT Testing 1 - Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness.

Experimental: IFT Testing 2 - Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness.

Experimental: IFT Testing 3 - Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness.

Experimental: IFT Testing 4 - Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness.


Other interventions: IFT Testing1
Command List A

Other interventions: IFT Testing 2
Command List B

Other interventions: IFT Testing 3
Command List C

Other interventions: IFT Testing 4
Command List D
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Responsiveness
Timepoint [1] 0 0
Intra-operative
Secondary outcome [1] 0 0
Patient Reported Confusion Following Emergence
Timepoint [1] 0 0
15 minutes and 60 minutes after PACU admission
Secondary outcome [2] 0 0
EEG
Timepoint [2] 0 0
Intra-operative
Secondary outcome [3] 0 0
Anesthesia Awareness with Recall
Timepoint [3] 0 0
24 hours and 7 days post-op
Secondary outcome [4] 0 0
Anesthesia Satisfaction
Timepoint [4] 0 0
24 hours and 7 days post-op
Secondary outcome [5] 0 0
Predisposing Factors
Timepoint [5] 0 0
Pre-operative

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2019
Sample size
Target
Accrual to date
Final
344
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cairns Hospital - Cairns
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Germany
State/province [5] 0 0
Aachen
Country [6] 0 0
Germany
State/province [6] 0 0
Munich
Country [7] 0 0
Israel
State/province [7] 0 0
Haifa
Country [8] 0 0
Netherlands
State/province [8] 0 0
Groningen
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wisconsin, Madison
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Rambam Health Care Campus
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Groningen
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Centre Hospitalier Regional de la Citadelle
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
RWTH Aachen University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Pennsylvania
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Ludwig-Maximilians - University of Munich
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Cornell University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Cairns Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Government body
Name [9] 0 0
Auckland District Health Board
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Waikato Hospital
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test (IFT) responder while under anesthetic.
Trial website
https://clinicaltrials.gov/study/NCT03503357
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Sanders, MBBS, PhD, FRCA
Address 0 0
University of Wisconsin, Madison
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03503357