ConsCIOUS2 Study of the Isolated Forearm Technique Commands
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|ClinicalTrials.gov Identifier: NCT03503357|
Recruitment Status : Completed
First Posted : April 19, 2018
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Awareness||Other: IFT Testing1 Other: IFT Testing 2 Other: IFT Testing 3 Other: IFT Testing 4||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||333 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|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|
|Actual Study Start Date :||April 4, 2018|
|Actual Primary Completion Date :||December 23, 2019|
|Actual Study Completion Date :||December 23, 2019|
Experimental: IFT Testing 1
Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness.
Other: IFT Testing1
Command List A
Other Name: Command List A
Experimental: IFT Testing 2
Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness.
Other: IFT Testing 2
Command List B
Other Name: Command List B
Experimental: IFT Testing 3
Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness.
Other: IFT Testing 3
Command List C
Other Name: Command List C
Experimental: IFT Testing 4
Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness.
Other: IFT Testing 4
Command List D
Other Name: Command List D
- Responsiveness [ Time Frame: Intra-operative ]Identify the incidence of IFT responsiveness following intubation assessed by hand squeezing response following a randomized command sequence to assess for non-specific responses.
- Patient Reported Confusion Following Emergence [ Time Frame: 15 minutes and 60 minutes after PACU admission ]Test the association between intra-operative IFT responsiveness and patient reported confusion following emergence from anesthesia and objectively assessed confusion using the NuDesc
- EEG [ Time Frame: Intra-operative ]Collect EEG data to identify monitoring patterns that discriminate responders and non-responders
- Anesthesia Awareness with Recall [ Time Frame: 24 hours and 7 days post-op ]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
- Anesthesia Satisfaction [ Time Frame: 24 hours and 7 days post-op ]Identify changes in patient satisfaction associated with IFT responsiveness via a patient satisfaction questionnaire administered 24 hours and 7 days postoperatively.
- Predisposing Factors [ Time Frame: Pre-operative ]Chart review of demographic factors that predispose to IFT responsiveness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503357
|United States, New York|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53703|
|Centre Hospitalier Regional de la Citadelle|
|RWTH Aachen University|
|University of Munich|
|Rambam Health Care Campus|
|University of Groningen|
|Auckland District Health Board|
|Auckland, New Zealand|
|Hamilton, New Zealand|
|Principal Investigator:||Robert Sanders, MBBS, PhD, FRCA||University of Wisconsin, Madison|