ConsCIOUS2 Study of the Isolated Forearm Technique Commands

Anesthesia Awareness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503357
• Other study ID #: 2017-0728
• Secondary ID: A530900SMPH\ANES
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia Awareness
• Intraoperative Awareness

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