Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A530900 | Other Identifier | UW Madison | |
| SMPH\ANESTHESIOLOGY\ANESTHESIO | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rambam Health Care Campus | OTHER |
| University of Groningen | OTHER |
| Centre Hospitalier Régional de la Citadelle | OTHER |
| RWTH Aachen University |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFT Testing 1 | Experimental | Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness. |
|
| IFT Testing 2 | Experimental | Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness. |
|
| IFT Testing 3 | Experimental | Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness. |
|
| IFT Testing 4 | Experimental | Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IFT Testing1 | Other | Command List A |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| EEG |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Sanders, MBBS, PhD, FRCA | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornell University | New York | New York | 10065 | United States | ||
| University of Pennsylvania |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058926 | Intraoperative Awareness |
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| OTHER |
| University of Pennsylvania | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
| Cornell University | OTHER |
| Cairns Hospital | UNKNOWN |
| Auckland District Health Board | OTHER_GOV |
| Waikato Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| IFT Testing 2 | Other | Command List B |
|
|
| IFT Testing 3 | Other | Command List C |
|
|
| IFT Testing 4 | Other | Command List D |
|
|
Collect EEG data to identify monitoring patterns that discriminate responders and non-responders |
| Intra-operative |
| 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 |
| 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 |
| Predisposing Factors | Chart review of demographic factors that predispose to IFT responsiveness. | Pre-operative |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53703 | United States |
| Cairns Hospital | Cairns | Australia |
| Centre Hospitalier Regional de la Citadelle | Liège | Belgium |
| RWTH Aachen University | Aachen | Germany |
| University of Munich | Munich | Germany |
| Rambam Health Care Campus | Haifa | Israel |
| University of Groningen | Groningen | Netherlands |
| Auckland District Health Board | Auckland | New Zealand |
| Waikato Hospital | Hamilton | New Zealand |