Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

NCT06387953 | Withdrawn FDA Device

• 1 other identifier: STUDY00019480
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Rescue pharmacologic treatment of agitation

  From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)

Other Outcomes (1)

• Patient State Index

  From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)

Study Arms (2)

Bridge Therapy

ACTIVE COMPARATOR

Subjects receive the Bridge therapy

Device: Bridge Therapy

Placebo

PLACEBO COMPARATOR

Subjects receive a placebo or sham therapy

Device: Sham Therapy

Interventions

Bridge Therapy 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.

Bridge Therapy

Sham Therapy 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-90
• English Speaking
• ASA Physical Status between I-IV
• Undergoing a surgical procedure at HMC
• Patient answers "yes" to one of the following below:
• Do you drink 7 or more alcoholic beverages per week?
• Do you use (smoke or eat) cannabis (or other recreational drugs) on a weekly basis?
• Have you felt disoriented, aggressive, angry, or delirious after waking up from a previous surgery?
• 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?
• Have you been diagnosed with post-traumatic stress disorder (PTSD)?

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Bridge Therapy

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jeffrey Kirsch, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 29, 2024
• Study Start: August 27, 2024
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share