NCT06387953

Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-08-27
• Primary completion: 2024-08-27
• Completion: 2024-08-27
• First posted: 2024-04-29
• Last updated: 2024-10-16

Regulatory

• FDA-regulated device study