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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03503357
Other study ID # 2017-0728
Secondary ID A530900SMPH\ANES
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2018
Est. completion date December 23, 2019

Study information

Verified date December 2021
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 344
Est. completion date December 23, 2019
Est. primary completion date December 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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. 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


Related Conditions & MeSH terms


Intervention

Other:
IFT Testing1
Command List A
IFT Testing 2
Command List B
IFT Testing 3
Command List C
IFT Testing 4
Command List D

Locations

Country Name City State
Australia Cairns Hospital Cairns
Belgium Centre Hospitalier Regional de la Citadelle Liège
Germany RWTH Aachen University Aachen
Germany University of Munich Munich
Israel Rambam Health Care Campus Haifa
Netherlands University of Groningen Groningen
New Zealand Auckland District Health Board Auckland
New Zealand Waikato Hospital Hamilton
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Cornell University New York New York
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (11)

Lead Sponsor Collaborator
University of Wisconsin, Madison Auckland District Health Board, Cairns Hospital, Centre Hospitalier Regional de la Citadelle, Cornell University, Ludwig-Maximilians - University of Munich, Rambam Health Care Campus, RWTH Aachen University, University of Groningen, University of Pennsylvania, Waikato Hospital

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Germany,  Israel,  Netherlands,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 15 minutes and 60 minutes after PACU admission
Secondary EEG Collect EEG data to identify monitoring patterns that discriminate responders and non-responders Intra-operative
Secondary 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 24 hours and 7 days post-op
Secondary Anesthesia Satisfaction Identify changes in patient satisfaction associated with IFT responsiveness via a patient satisfaction questionnaire administered 24 hours and 7 days postoperatively. 24 hours and 7 days post-op
Secondary Predisposing Factors Chart review of demographic factors that predispose to IFT responsiveness. Pre-operative
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