Immersive Virtual Reality in Mechanically Ventilated Patients

NCT03569358 | Unknown

• 1 other identifier: 201802-00023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

New or worsening cognitive impairment occurs in up to 58% of survivors of critical illnesses and are long-lasting with significant disability and socioeconomic cost. There are currently no known interventions that reduce the incidence of cognitive impairment after critical illnesses. Immersive Virtual Reality (IVR) is the use of technology to create a perception of presence in a three-dimensional, computer-generated interactive simulated environment. Prior clinical studies have demonstrated potential efficacy in rehabilitation of severe traumatic brain injury. The investigators propose a preliminary study for the evaluation of safety, tolerability, and early efficacy of immersive virtual reality for early neurocognitive stimulation in critically-ill, mechanically ventilated patients. The investigators hypothesize that the use of IVR technology for early neurocognitive simulation is safe and tolerable in these patients. This study will also evaluate whether early application of IVR in critically ill, mechanically ventilated subjects, can provide neurocognitive stimulation. 30 patients admitted to the intensive care unit for acute respiratory failure or septic shock will be evaluated for recruitment. 10 patients will be in the control group and 20 patients would have 2 sessions of IVR planned daily for a maximum of 3 days. Assessment of safety will involve monitoring for physiological derangements in heart rate, respiratory rate, pulse oximetry and blood pressure during the IVR session. Assessment of tolerability will involve monitoring for increased agitation. Assessment of early efficacy will involve evaluation of visual attention during the IVR session. 5-channel electroencephalogram would aim to detect objective changes in visual event-related potentials and the IVR headgear will incorporate eye-tracking technology. To conclude, should IVR be feasible and safe, future interventional studies may be planned to investigate its impact on reduction in the use of sedatives, analgesia, delirium incidence and severity of cognitive impairment associated with critical illness.

Conditions

Mechanical Ventilation; Virtual Reality; Delirium

Keywords

Randomised Controlled Study; Unblinded; Electroencephalogram; Feasibility

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the study would be the number of patients who are able to complete immersive virtual reality session meeting both safety and tolerability criteria.

  The IVR intervention would be considered safe and tolerable if the difference in number of subjects having a composite endpoint of both safety and tolerability end-points in the intervention arm is not 20% more than the control arm. Demonstration of safety is the composite of non-occurrence of any 4 physiological events as follows: greater than 30% variability in the heart rate; greater than 30% variability in respiratory rate; systolic blood pressure of less than 90mmHg or more than 160mmHg; pulse oximetry of less than 90%. Demonstration of tolerability is the non-occurrence of the event that Richmond Agitation-Sedation Score (RASS) greater than or equal to +2 during the intervention, sustained for more than 3 minutes.

  4 days

Secondary Outcomes (2)

• Exploratory use of EEG changes to quantify differences in attention in delirious mechanically ventilated patients.

  4 days

• Assessment of visual attention in delirious subjects using virtual-reality integrated eye-tracking software.

  4 days

Study Arms (3)

Virtual Reality and EEG Interventions

EXPERIMENTAL

In the interventional arm, 20 subjects will receive twice daily sessions of immersive virtual reality for a maximum of 15 minutes, with EEG headband recording starting 5 minutes prior to and 5 minutes after the intervention, for a maximum of 4 consecutive days.

Device: Immersive Virtual Reality; Device: EEG headband

EEG Intervention group

ACTIVE COMPARATOR

In the control arm, 10 subjects would have EEG recorded for 25 mins twice daily, with a minimum of 4 hours intervening, for 3 consecutive days, with the EEG headband. There would be no immersive virtual reality sessions.

Device: EEG headband

Healthy Volunteers

ACTIVE COMPARATOR

At the completion of the above intensive care study recruitment, demographic data of the interventional immersive virtual reality arm would analysed to recuit 10 age-matched healthy volunteers with no known cognitive disorders or visual impairment. This is to compare study data with healthy controls. A 25 minute session consisting of 15 minutes of immersive virtual reality and 5 minutes of EEG recording with the EEG headband before and after the intervention would be performed. Eye-tracking and EEG data from these groups of patients would be compared against subjects in both arms of the study performed in the intensive care unit to investigate for exploratory differences.

Device: Immersive Virtual Reality; Device: EEG headband

Interventions

Immersive Virtual Reality DEVICE

The immersive virtual reality headgear used is the commercially available FOVE VR headset. It incorporates a 2560x1440 pixel display, position tracking-and eye-tracking. The headset weight 520g with adjustable velcro straps. Softwares are run via a computer connected by HDMI or USB cables.

Healthy Volunteers; Virtual Reality and EEG Interventions

EEG headband DEVICE

The EEG headband is commercially available MUSE band. It incorporates 4-channel dry electrode EEG system where data can be recorded with bluetooth connection.

EEG Intervention group; Healthy Volunteers; Virtual Reality and EEG Interventions

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Group
• Patients aged 21 to 75
• Both genders and all races
• Acute respiratory failure or septic shock as indications for critical care admission
• Anticipated to require mechanical ventilation for a minimum of 48 hours after enrolment
• GCS of E3VTM4 or more
• Healthy Volunteer Group
• \) Age-matched to the subjects of the interventional arm of the ICU subjects.

You may not qualify if:

• Patient Group
• Patients who are actively using an interactive device in the intensive care unit prior to enrolment
• Illnesses with a terminal prognosis within 3 months
• Prisoners and pregnant patients
• Blind or deaf patients
• Premorbid baseline cognitive impairment
• Neurological diseases affecting cognition as the cause of intensive care admission including but not limited to ischaemic and haemorrhagic strokes, meningitis, encephalitis, traumatic brain injuries and status epilepticus.
• Severe critical illness with imminent mortality
• Critical illness requiring the use of paralytic agents
• Use of vasopressor dose more than an equivalent of Noradrenaline 0.5 mcg/kg/min
• Use of fractional inspired oxygen on mechanical ventilation of more than 0.8.
• Presence of external facial, skull vault or cervical injuries, or deformities, precluding the safe application of the VR headset and EEG band.
• Participation declined by attending intensivist.
• Healthy Volunteer Group
• Known prior neurological or neurocognitive disease.

Sponsors & Collaborators

• Changi General Hospital: lead
• BetaSight Technologies Pte Ltd: collaborator
• Institute for Infocomm Research: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

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Related Links

• Demonstration of the FOVE immersive virtual reality head-mounted display
• Demonstration of the MUSE EEG headband

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jessica LS Quah, M.B.B.S.

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica LS Quah, M.B.B.S.

CONTACT

65-67888833; jessica_quah@cgh.com.sg

Xin Hui Sam

CONTACT

65-67888833; xin_hui_sam@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 26, 2018
• Study Start: July 2, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

SG (1)