Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT03569358
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT03569358
Study Brief:
Protocol Section:
NCT03569358