Intraoperative VR for Older Patients Undergoing TKA

Study Overview
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Brief Summary
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The objective of this study is to investigate whether the use of virtual reality (VR) during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative requirements while maintaining high levels of patient satisfaction as compared to both a music and sham VR + usual care control.

Detailed Description
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The investigators will conduct a three-armed randomized controlled trial with the following aims: Specific Aim 1: Evaluate whether the use of VR during TKA can facilitate a reduction in intraoperative propofol dose required for patient comfort as compared to music and sham VR + usual care controls. Hypotheses: Patients in both the VR and music groups will demonstrate reductions in propofol dose compared to sham VR + usual care controls. A reduction in propofol dose between the VR and music group will be smaller in magnitude. Specific Aim 2: Assess the effect of VR during TKA on patient reported outcomes including overall satisfaction, pain, and anxiety as compared to music and sham VR + usual care controls. Hypotheses: Patients in the VR group will report significantly higher satisfaction and better control of pain and anxiety than those in the music group and usual care group. Specific Aim 3: Explore the potential effects of VR during TKA on other key secondary outcomes of perioperative efficiency, postoperative cognition, and functional recovery. Hypotheses: Patients in the VR group will have shorter post-anaesthesia care unit (PACU) length of stay as compared to sham VR + usual care controls. The effect of VR on postoperative delirium, postoperative cognitive decline, postoperative opioid use and functional recovery will be exploratory endpoints.

Official Title
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Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Other: Virtual Reality Immersive Relaxation
* Other: Immersive Audio Experience
* Other: Sham Virtual Reality Experience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia Exclusion Criteria: Complex or revision surgeries Patients scheduled for same day TKA Open wounds or active infection of the face or eye area History of seizures or other symptom linked to an epileptic condition Patients who plan to wear hearing aids during the procedure Patients with a pacemaker or other implanted medical device Droplet or airborne precautions (as determined by local infection control policy) Non-English speaking Patients booked to receive general anesthesia Moderate to severe dementia Drop-Out Criteria: MoCA <10 (this test will be administered on Day of Enrollment)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Research participants will be randomized to one of three groups (2:2:1 allocation): Immersive VR group Music group Sham VR + usual care control The first 6 patients enrolled will be assigned to the VR group for the purposes of a pilot phase with the objective of identifying and refining any issues with the intervention. Data for these patients will not be included in the statistical analysis.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immersive VR group<br>Patients in the Immersive VR group will don a VR headset connected to a software platform on a tablet, as well as noise cancelling headphones. Patients can choose their desired experience within the VR software from a selection of immersive environments and/or video content. Examples include sitting in a canoe on a river, on a peaceful meadow or in a forest. Patients also have the option to listen to guided meditation or select from a library of videos to watch on a web-based user interface. To reduce the influence of the anesthesia provider on the determination of sedative requirements, patients will administer their own sedation according to their needs for relaxation and comfort using a patient controlled system. | Other: Virtual Reality Immersive Relaxation<br>* The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.<br>|
| Active Comparator: Music group<br>Patients randomized to the Music group will be equipped with VR headsets but won't view any content. They will also be equipped with noise cancelling headphones in the same fashion as the immersive VR group. A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient. Patients in the Sham VR group will also use patient controlled sedation. | Other: Immersive Audio Experience<br>* A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient.<br>|
| Sham Comparator: Sham VR + Usual Care Control Group<br>Subjects in the control group will wear VR headsets and headphones but will not view any content or listen to any audible content. They will undergo Monitored Anesthesia Care (MAC) according to a prespecified protocol targeting light or moderate sedation with a propofol infusion. | Other: Sham Virtual Reality Experience<br>* Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Propofol Dose | Total propofol dose (mg/kg/min) administered intraoperatively | Duration of the procedure, on average 1 to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative and Postoperative Opioids | Total intraoperative and postoperative opioid equivalent doses administered | Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively | 
| Intraoperative Anesthesia Maneuvers | Assessment of intraoperative vital signs and anesthesia maneuvers potentially related to over-sedation (i.e. airway interventions, use of airway assist devices, conversion to general anesthesia) | Duration of the procedure, on average 1 to 3 hours | 
| Length of PACU stay | The length of the patients stay in the Post Anesthesia Care Unit. | Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours | 
| Postoperative Pain | Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome). Using this numeric rating scale, patients will be asked to describe both the maximum and average level of pain | Measured on postoperative day zero and one, starting with PACU scores | 
| Satisfaction with Anesthesia | Patients will rate their overall satisfaction with their perioperative anesthesia care using the Iowa Satisfaction with Anesthesia Scale. They will also be asked to rate their satisfaction with their communication with their anesthesia providers. | Within an hour of admission to the postoperative anesthesia care unit | 
| Satisfaction with Recovery | Patients will rate their overall satisfaction with their recovery from surgery using the QOR15. Additionally, patients will be asked how frequently they find themselves reacting to pain. | Postoperative day one | 
| Postoperative Delirium | A member of the research staff will meet with the patient and complete the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to assess the incidence of postoperative delirium. | Measured daily on each postoperative day, starting on postoperative day 1 until postoperative day 7. | 
| Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder | Cognitive function will be assessed using the telephonic version of the Montreal Cognitive Assessment (MoCA). | Assessment will take place on day of enrollment and then at one week (+/- 48 hours) and one month postoperatively (+/- 7 days). | 
| Assessment of Knee Pain and Function | As part of standard pre and post TKA assessment, patients will be administered the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Patient-Reported Outcome Measures (KOOS-JR PROM) to assess the degree of limitation in activity and pain from their knee ailment. | Assessments will take place within 7 days of the initial clinic visit and within 7 days of the initial postoperative clinic visit, typically one month after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality