NCT03503357

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
7 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

March 27, 2018

Last Update Submit

December 2, 2021

Conditions

Anesthesia Awareness

Keywords

ConsciousnessElectroencephalographyAnesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Intra-operative

Secondary Outcomes (5)

  • Patient Reported Confusion Following Emergence

    15 minutes and 60 minutes after PACU admission

  • EEG

    Intra-operative

  • Anesthesia Awareness with Recall

    24 hours and 7 days post-op

  • Anesthesia Satisfaction

    24 hours and 7 days post-op

  • Predisposing Factors

    Pre-operative

Study Arms (4)

IFT Testing 1

EXPERIMENTAL

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

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.

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.

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.

Other: IFT Testing 4

Interventions

IFT Testing1OTHER

Command List A

Also known as: Command List A
IFT Testing 1
IFT Testing 2OTHER

Command List B

Also known as: Command List B
IFT Testing 2
IFT Testing 3OTHER

Command List C

Also known as: Command List C
IFT Testing 3
IFT Testing 4OTHER

Command List D

Also known as: Command List D
IFT Testing 4

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cornell University

New York, New York, 10065, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53703, United States

Location

Cairns Hospital

Cairns, Australia

Location

Centre Hospitalier Regional de la Citadelle

Liège, Belgium

Location

RWTH Aachen University

Aachen, Germany

Location

University of Munich

Munich, Germany

Location

Rambam Health Care Campus

Haifa, Israel

Location

University of Groningen

Groningen, Netherlands

Location

Auckland District Health Board

Auckland, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Sanders, MBBS, PhD, FRCA

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 19, 2018

Study Start

April 4, 2018

Primary Completion

December 23, 2019

Study Completion

December 23, 2019

Last Updated

December 3, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)NZ(2)AU(1)BE(1)DE(2)IL(1)US(3)