NCT03503357

ConsCIOUS2 Study of the Isolated Forearm Technique Commands

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia Awareness

Interventions

Type	Name	Description
OTHER	IFT Testing1	Command List A
OTHER	IFT Testing 2	Command List B
OTHER	IFT Testing 3	Command List C
OTHER	IFT Testing 4	Command List D

Timeline

• Start date: 2018-04-04
• Primary completion: 2019-12-23
• Completion: 2019-12-23
• First posted: 2018-04-19
• Last updated: 2021-12-03

Locations

11 sites across 7 countries: United States, Australia, Belgium, Germany, Israel, Netherlands, New Zealand