Clinical trial NCT03503357: ConsCIOUS2 Study of the Isolated Forearm Technique Commands
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Awareness
Keywords: Consciousness
Electroencephalography
Anesthesia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Rambam Health Care Campus
name: University of Groningen
name: Centre Hospitalier Regional de la Citadelle
name: RWTH Aachen University
name: University of Pennsylvania
name: Ludwig-Maximilians - University of Munich
name: Cornell University
name: Cairns Hospital
name: Auckland District Health Board
name: Waikato Hospital
First posted: 2018-04-19
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Responsiveness
timeFrame: Intra-operative
Secondary outcomes:
measure: Patient Reported Confusion Following Emergence
timeFrame: 15 minutes and 60 minutes after PACU admission
measure: EEG
timeFrame: Intra-operative
measure: Anesthesia Awareness with Recall
timeFrame: 24 hours and 7 days post-op
measure: Anesthesia Satisfaction
timeFrame: 24 hours and 7 days post-op
measure: Predisposing Factors
timeFrame: Pre-operative
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell University
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Cairns
country: Australia
facility: Cairns Hospital
city: Liège
country: Belgium
facility: Centre Hospitalier Regional de la Citadelle
city: Aachen
country: Germany
facility: RWTH Aachen University
city: Munich
country: Germany
facility: University of Munich
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Groningen
country: Netherlands
facility: University of Groningen
city: Auckland
country: New Zealand
facility: Auckland District Health Board
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: University of Wisconsin, Madison
name: Robert Sanders, MBBS, PhD, FRCA
role: PRINCIPAL_INVESTIGATOR
References: