Intraoperative VR for Older Patients Undergoing TKA

Total Knee Arthroplasty Clinical Trial

Official title:

Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748549
• Other study ID #: 2020P001176
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Brian P O'Gara, MD,MPH
• Phone: 617-754-3189
• Email: bpogara[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 131
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 or Non-Spanish 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)

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Other:
• Virtual Reality Immersive Relaxation
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.
• Immersive Audio Experience
A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient.
• Sham Virtual Reality Experience
Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Israel-United States Binational Industrial Research and Development Foundation, XRHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Propofol Dose	Total propofol dose (mg/kg/min) administered intraoperatively	Duration of the procedure, on average 1 to 3 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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).
Secondary	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.