Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

This is a randomized, prospective, double-blinded (patient and outcome-assessor) trial. Our goal is to assess efficacy of Bridge Therapy (versus sham bridge therapy) to prevent emergence agitation following general anesthesia.

Primary Objective: Activation of Bridge Therapy from the time of the pre incision "time out" until 24 hours after admission to the PACU (Post Anesthesia Care Unit) is associated with reduced frequency and intensity of emergence agitation.

Secondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation.

Tertiary Objective: Activation of Bridge Therapy during a stable anesthetic state is associated with a reduced Patient State Index as measured on Sedline

Study Overview

• Status: Withdrawn
• Conditions: Emergence Delirium; Agitation, Emergence
• Intervention / Treatment: Device: Bridge Therapy; Device: Sham Therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-90
2. English Speaking
3. ASA Physical Status between I-IV
4. Undergoing a surgical procedure at HMC

5. Patient answers "yes" to one of the following below:

   1. Do you drink 7 or more alcoholic beverages per week?
   2. Do you use (smoke or eat) cannabis (or other recreational drugs) on a weekly basis?
   3. Have you felt disoriented, aggressive, angry, or delirious after waking up from a previous surgery?
   4. Have you been told by a care provider or friend/family member that you woke up from surgery in the past disoriented, confused, or aggressive/angry?
   5. Have you been diagnosed with post-traumatic stress disorder (PTSD)?

Exclusion Criteria:

1. <18 years old, >90 years old
2. Intubated patients
3. Pregnant by HMC lab test
4. Non-English Speaking
5. Has a cardiac pacemaker
6. Hx of bleeding condition
7. Skin issues where the device would be applied, this includes: Dermatitis, Psoriasis vulgaris, skin breakdown, skin integrity compromised.
8. Plan to use dexmedetomidine as part of the anesthetic technique
9. Plan to use sedline for clinical anesthetic management during operating procedure.
10. Patients with previous history of sensitivity to compound benzoin tincture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bridge Therapy; Subjects receive the Bridge therapy	Device: Bridge Therapy; After the patient has been intubated in the operating room - the Bridge device intervention will be applied to the subject's ear by a trained study team member. At the time of the pre-incision pause, Initiation of the intervention (Bridge therapy) will begin and will be continued throughout the surgery. The intervention will continue for 24 hours after extubation.
Placebo Comparator: Placebo; Subjects receive a placebo or sham therapy	Device: Sham Therapy; After the patient has been intubated in the operating room - the Bridge device intervention will be applied to the subject's ear by a trained study team member. At the time of the pre-incision pause, Initiation of the intervention (Sham therapy) will begin and will be continued throughout the surgery. The intervention will continue for 24 hours after extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence agitation	Frequency of emergence agitation following general anesthesia will be collected every 15 minutes in the PACU. Once discharged from the PACU this will be measured every 12 hours.	From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
Emergence agitation	Intensity of emergence agitation following general anesthesia will be measured by the Riker Sedation Agitation Scale (RSAS). The maximum score is 7, the minimum score is 1. A high scores means a worse outcome (higher agitation).	time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue pharmacologic treatment of agitation	Incidence of rescue pharmacologic treatment of agitation following general anesthesia. This will be measured by the number of times rescue pharmacological treatment was given.	From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient State Index	Patient State Index or PSI is a clinically validated measure of the effect of anesthesia and sedation. PSI is measured on a Sedline Sedation Monitor. PSI values range from 0 (total cortical silence) to 100 (awake state), and 25-50 indicates the optimal hypnotic state for surgical anesthesia.	From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Jeffrey Kirsch, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Actual): August 27, 2024
• Study Completion (Actual): August 27, 2024

Study Registration Dates

• First Submitted: March 30, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Aberrant Motor Behavior in Dementia; Psychomotor Agitation; Emergence Delirium
• Other Study ID Numbers: STUDY00019480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes