Clinical trial NCT04748549: Intraoperative VR for Older Patients Undergoing TKA
Official title: Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Virtual Reality
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Israel-United States Binational Industrial Research and Development Foundation
name: XRHealth
First posted: 2021-02-10
Enrollment: 131
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Research participants will be randomized to one of three groups (2:2:1 allocation):

1. Immersive VR group
2. Music group
3. 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia
* English or Spanish speaking patients

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 or Non-Spanish speaking
* Moderate to severe dementia

Drop-Out Criteria:

* MoCA \<10 (this test will be administered on Day of Enrollment)

Primary outcomes:
measure: Intraoperative Propofol Dose
timeFrame: Duration of the procedure, on average 1 to 3 hours
Secondary outcomes:
measure: Intraoperative and Postoperative Opioids
timeFrame: Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively
measure: Intraoperative Anesthesia Maneuvers
timeFrame: Duration of the procedure, on average 1 to 3 hours
measure: Length of PACU stay
timeFrame: Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours
measure: Postoperative Pain
timeFrame: Measured on postoperative day zero and one, starting with PACU scores
measure: Satisfaction with Anesthesia
timeFrame: Within an hour of admission to the postoperative anesthesia care unit
measure: Satisfaction with Recovery
timeFrame: Postoperative day one
measure: Postoperative Delirium
timeFrame: Measured daily on each postoperative day, starting on postoperative day 1 until postoperative day 7.
measure: Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder
timeFrame: Assessment will take place on day of enrollment and then at one week (+/- 48 hours) and one month postoperatively (+/- 7 days).
measure: Assessment of Knee Pain and Function
timeFrame: 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.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Brian P O'Gara, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: