Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

Emergence Delirium Clinical Trial

Official title:

Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06387953
• Other study ID #: STUDY00019480
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: Adrienne James
• Phone: 206-744-4634
• Email: ajames1[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitation, Emergence
• Emergence Delirium
• Psychomotor Agitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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)
Primary	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	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)