Virtual Reality for ICU Delirium Prevention

Official title

VR for ICU Delirium Prevention

Overview

The purpose of this study is to evaluate whether daily exposure to immersive virtual reality (VR) can reduce the incidence of delirium in high-risk, non-intubated ICU patients. Participants will be randomized to either standard ICU care or standard care plus once-daily 15-minute VR sessions consisting of calming natural scenes, guided meditation, and music. The study population includes adult surgical ICU patients at Cedars-Sinai who are CAM-ICU negative at enrollment and possess at least one established risk factor for delirium. Outcomes will include the incidence and duration of delirium, ICU and hospital length of stay, feasibility of the VR intervention, and the frequency of adverse events. By targeting a high-risk population with an innovative non-pharmacologic therapy, this trial aims to generate data to support integration of VR into ICU delirium prevention protocols.

Interventions

• Device Virtual Reality therapeutics
  Patients will receive daily VR sessions for up to 5 days in addition to regular delirium prevention measures in the ICU

Primary outcome measures

• Incidence of ICU Delirium [Time frame: From enrollment in the study until ICU discharge. Assessed Day 1 in the morning and evening for the duration of the ICU admission, up to 24 months from enrollment.]

Secondary outcome measures (5)

• Duration of ICU delirium [Time frame: From the time of study enrollment until the time of discharge from the ICU, up to 24 months from enrollment.]
• ICU-LOS [Time frame: From time admitted to the ICU until discharge from the ICU, up to 24 months from enrollment.]
• H-LOS [Time frame: From time admitted to the hospital until discharge from the hospital, up to 24 months from enrollment.]
• Acceptability by patients [Time frame: From time enrolled in the study until the patient has completed the study interventions (either on discharge from the ICU or after 5 days of interventions, whichever comes first), from Day 1 until Day 5 after enrollment.]
• Number of adverse events [Time frame: Adverse events related to VR, such as nausea, dizziness, seizures, will be assessed from the time of enrollment in the study up until the time of discharge from the hospital, from time of enrollment on Day 1 until Day 5 after enrollment, if applicable.]

Eligibility criteria

Inclusion criteria

• Individuals who are currently admitted to the SICU at Cedars-Sinai Medical Center
• Expected ICU stay >48 hours
• Richmond Agitation Sedation Scale (RASS) score between -1 to +2.
• CAM-ICU negative
• 1≤ risk factor for delirium (Age ≥ 65 years old, history of cognitive impairment, sepsis, Sequential Organ Failure Assessment (SOFA) score >5, history of alcohol or benzodiazepine abuse, recent major surgery)

Exclusion criteria

• Unwilling and/or unable to participate
• Intubation of tracheostomy
• Self-reported history of severe motion sickness
• Inability to follow commands (e.g. severe aphasia, deafness, GCS<13)
• The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted device (HMD
• Those that require corrective lenses -2.5 or stronger that cannot be corrected with contact lenses
• Having had a seizure in the past year
• Unable to understand the instructions or to consent to participation in the study.
• Those who are pregnant
• Hemodynamic instability (MAP<65 despite support)
• End-of-life care
• Severe agitation or delirium (i.e. CAM-ICU + screen)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Cedars Sinai Medical Center — Los Angeles

Identifiers

NCT: NCT07357389 · STUDY00004538

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗