Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

NCT ID: NCT06387953

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-27
• Study Completion Date: 2024-08-27

Brief Summary

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

Conditions

Emergence Delirium; Agitation, Emergence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Bridge Therapy

Subjects receive the Bridge therapy

Group Type: ACTIVE_COMPARATOR

Bridge Therapy

Intervention Type: DEVICE

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

Subjects receive a placebo or sham therapy

Group Type: PLACEBO_COMPARATOR

Sham Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Kirsch

Professor: Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Kirsch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Other Identifiers

STUDY00019480

Identifier Type: -

Identifier Source: org_study_id