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Intraoperative VR for Older Patients Undergoing TKA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04748549
Recruitment Status : Not yet recruiting
First Posted : February 10, 2021
Last Update Posted : February 8, 2022
Sponsor:
Collaborators:
Israel-United States Binational Industrial Research and Development Foundation
XRHealth
Information provided by (Responsible Party):
Brian O'Gara, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Other: Virtual Reality Immersive Relaxation Other: Immersive Audio Experience Other: Sham Virtual Reality Experience Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 5 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 (Outcomes Assessor)
Masking Description: Assessors of the Confusion Assessment Method (CAM) and Montreal Cognitive Assessment (MoCA) will be blinded to group assignment.
Primary Purpose: Treatment
Official Title: Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Immersive VR group

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
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.

Active Comparator: Music group
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
A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient.

Sham Comparator: Sham VR + Usual Care Control Group
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
Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.




Primary Outcome Measures :
  1. Intraoperative Propofol Dose [ Time Frame: Duration of the procedure, on average 1 to 3 hours ]
    Total propofol dose (mg/kg/min) administered intraoperatively


Secondary Outcome Measures :
  1. Intraoperative and Postoperative Opioids [ Time Frame: Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively ]
    Total intraoperative and postoperative opioid equivalent doses administered

  2. Intraoperative Anesthesia Maneuvers [ Time Frame: Duration of the procedure, on average 1 to 3 hours ]
    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)

  3. Length of PACU stay [ Time Frame: Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours ]
    The length of the patients stay in the Post Anesthesia Care Unit.

  4. Postoperative Pain [ Time Frame: Measured on postoperative day zero and one, starting with PACU scores ]
    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

  5. Satisfaction with Anesthesia [ Time Frame: Within an hour of admission to the postoperative anesthesia care unit ]
    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.

  6. Satisfaction with Recovery [ Time Frame: Postoperative day one ]
    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.

  7. Postoperative Delirium [ Time Frame: Measured daily on each postoperative day, starting on postoperative day 1 until postoperative day 7. ]
    A member of the research staff will meet with the patient and complete the Confusion Assessment Method (CAM) to assess the incidence of postoperative delirium.

  8. Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder [ Time Frame: Assessment will take place on day of enrollment and then at one week (+/- 48 hours) and one month postoperatively (+/- 7 days). ]
    Cognitive function will be assessed using the telephonic version of the Montreal Cognitive Assessment (MoCA).

  9. Assessment of Knee Pain and Function [ Time Frame: 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. ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748549


Contacts
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Contact: Brian P O'Gara, MD,MPH 617-754-3189 bpogara@bidmc.harvard.edu
Contact: Evynne Gartner, BA egartner@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Israel-United States Binational Industrial Research and Development Foundation
XRHealth
Investigators
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Principal Investigator: Brian P O'Gara, MD,MPH Beth Israel Deaconess Medical Center
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Responsible Party: Brian O'Gara, Assistant Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04748549    
Other Study ID Numbers: 2020P001176
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian O'Gara, Beth Israel Deaconess Medical Center:
Virtual Reality