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Immersive Virtual Reality in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT03569358
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
BetaSight Technologies Pte Ltd
Institute for Infocomm Research
Information provided by (Responsible Party):
Jessica Quah Li Shan, Changi General Hospital

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.


Condition or disease Intervention/treatment Phase
Mechanical Ventilation Virtual Reality Delirium Device: Immersive Virtual Reality Device: EEG headband Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Safety, Tolerability, and Early Efficacy of Immersive Virtual Reality for Early Neurocognitive Stimulation in the Intensive Care Unit.
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : July 2, 2019
Estimated Study Completion Date : July 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Virtual Reality and EEG Interventions
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
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.

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

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

Active Comparator: Healthy Volunteers
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
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.

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




Primary Outcome Measures :
  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. [ Time Frame: 4 days ]
    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.


Secondary Outcome Measures :
  1. Exploratory use of EEG changes to quantify differences in attention in delirious mechanically ventilated patients. [ Time Frame: 4 days ]
    EEG data before, during and after the immersive VR sessions would be recorded and compared to subjects in the control arm and the healthy subjects group. The EEG patterns would be translated into an attention score developed by academic collaborator. The hypothesis is that visual and auditory attention during the immersive virtual reality intervention can be demonstrated with EEG signals with differences in the level of attention between subjects who have delirium as assessed by ICU-CAM scores, and those who do not have delirium. The degree of eye blinking and motion artefacts generated during the intervention may also be accurately quantified and compared between intervention and control groups.

  2. Assessment of visual attention in delirious subjects using virtual-reality integrated eye-tracking software. [ Time Frame: 4 days ]
    Assessment of eye movements is a potential tool for assessment of meaningful interaction in mechanically ventilated patients. The subjects would have eye movements recorded during the immersive virtual reality interventions. These would allow identification and quantification of the presence of saccadic eye movements, velocity and duration, as well as the presence and duration of smooth pursuit, to be compared between delirious and non-delirious subjects in the interventional groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient Group

    1. Patients aged 21 to 75
    2. Both genders and all races
    3. Acute respiratory failure or septic shock as indications for critical care admission
    4. Anticipated to require mechanical ventilation for a minimum of 48 hours after enrolment
    5. GCS of E3VTM4 or more

Healthy Volunteer Group

1) Age-matched to the subjects of the interventional arm of the ICU subjects.

Exclusion Criteria:

Patient Group

  1. Patients who are actively using an interactive device in the intensive care unit prior to enrolment
  2. Illnesses with a terminal prognosis within 3 months
  3. Prisoners and pregnant patients
  4. Blind or deaf patients
  5. Premorbid baseline cognitive impairment
  6. 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.
  7. Severe critical illness with imminent mortality
  8. Critical illness requiring the use of paralytic agents
  9. Use of vasopressor dose more than an equivalent of Noradrenaline 0.5 mcg/kg/min
  10. Use of fractional inspired oxygen on mechanical ventilation of more than 0.8.
  11. Presence of external facial, skull vault or cervical injuries, or deformities, precluding the safe application of the VR headset and EEG band.
  12. Participation declined by attending intensivist.

Healthy Volunteer Group

  1. Known prior neurological or neurocognitive disease.
  2. Baseline heart rate more than 100 beats per minute
  3. Baseline systolic blood pressure less than 100 mmHg or more than 160 mmHg
  4. Respiratory failure requiring supplemental oxygen

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): NCT03569358


Contacts
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Contact: Jessica LS Quah, M.B.B.S. 65-67888833 ext 0 jessica_quah@cgh.com.sg
Contact: Xin Hui Sam 65-67888833 ext 0 xin_hui_sam@cgh.com.sg

Locations
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Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: CTRU CGH    67888833      
Sponsors and Collaborators
Changi General Hospital
BetaSight Technologies Pte Ltd
Institute for Infocomm Research
Investigators
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Principal Investigator: Jessica LS Quah, M.B.B.S. Changi General Hospital

Additional Information:
Publications:

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Responsible Party: Jessica Quah Li Shan, Associate Consultant, Changi General Hospital
ClinicalTrials.gov Identifier: NCT03569358     History of Changes
Other Study ID Numbers: 201802-00023
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Jessica Quah Li Shan, Changi General Hospital:
Randomised Controlled Study
Unblinded
Electroencephalogram
Feasibility

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders