ConsCIOUS2 Study of the Isolated Forearm Technique Commands



Status:Recruiting
Healthy:No
Age Range:18 - 40
Updated:3/30/2019
Start Date:April 4, 2018
End Date:April 1, 2022
Contact:Robert Sanders, MBBS, PhD, FRCA
Email:robert.sanders@wisc.edu
Phone:608-263-8100

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
4
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Cairns,
?
mi
from
Cairns,
Click here to add this to my saved trials
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Robert Sanders, 608-263-8100
Phone: 608-263-8100
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials