Emergence DeliriumNCT06387953
Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy
A study testing Bridge Therapy in people with Emergence Delirium and Agitation, Emergence, run by University of Washington.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Emergence Delirium, Agitation, Emergence
- What is being tested?
- Bridge Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2024to 27 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?
Show all 10Show fewer
- 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)?
Who cannot join
- <18 years old, >90 years old
- Intubated patients
- Pregnant by HMC lab test
- Non-English Speaking
- Has a cardiac pacemaker
- Hx of bleeding condition
Show all 10Show fewer
- 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.
About this study
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.
Read more
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
- Being tested
- Bridge Therapy, Sham Therapy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridge TherapyDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bridge Therapy | Active comparator | Subjects receive the Bridge therapy Receives: Device: Bridge Therapy |
| Placebo | Placebo comparator | Subjects receive a placebo or sham therapy Receives: Device: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
Secondary outcomes (1)
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.
Measured: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start27 Aug 2024
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Why it stopped: The sponsor of the study and the University of Washington were not able to come to an agreement on the intellectual property provisions. Therefore, this study will not be carried out.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Kirsch, University of Washington
- Investigators
- Jeffrey Kirsch, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387953
- Sponsor's protocol ID
- STUDY00019480
- Status last verified
- Oct 2024
- First submitted
- 30 Mar 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy
- ClinicalTrials.gov ID
- NCT06387953
- Acronym / sponsor ID
- STUDY00019480
- Conditions
- Emergence Delirium, Agitation, Emergence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor of the study and the University of Washington were not able to come to an agreement on the intellectual property provisions. Therefore, this study will not be carried out.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridge Therapy | Active comparator | Device: Bridge TherapySubjects receive the Bridge therapy |
| Placebo | Placebo comparator | Device: Sham TherapySubjects receive a placebo or sham therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (10 listed)
- <18 years old, >90 years old
- Intubated patients
- Pregnant by HMC lab test
- Non-English Speaking
- Has a cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridge TherapyAfter 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 | Bridge Therapy |
| Sham TherapyAfter 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. | Device | Placebo |
Primary outcome
Emergence agitation
Time frame: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
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.
Emergence agitation
Time frame: time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
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).
1 secondary outcome
Rescue pharmacologic treatment of agitation
Time frame: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Emergence Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Kirsch, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Bridge Therapy in people with Emergence Delirium and Agitation, Emergence, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence agitation (time frame: From time of the pre incision "time out" until 24 hours after admission to the PACU (Post-Anesthesia Care Unit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.