VR Interventions to Reduce the Prevalence of Delirium in ICU Patients
ConditionDelirium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPeking Union Medical College Hospital
About this trial
The goal of this clinical trial is to learn the effect of Virtual Reality Family Support System (VRFS) on reducing delirium in ICU mechanically ventilated patients. The main question it aims to answer is:
·Using VRFS for participant intervention, can it reduce the incidence of delirium and improve clinical outcomes?
Researchers will investigate whether the implementation of VRFS can reduce the number of delirium days and improve clinical outcomes.
Participants will:
* Receive the VRFS intervention until the endotracheal tube (ETT) is removed. * Have physiological data collected, including EEG, oxygen saturation levels, ECG, and blood pressure. * Keep a diary of delirium, dosage of sedative and analgesic drugs, the duration of mechanical ventilation, and ICU stays.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mechanical ventilation duration is expected to be greater than 24 hours;
ICU stay duration is expected to be greater than 72 hours;
Age is 18 years or older, with no upper age limit;
Language: Chinese.
Disqualifiers
Severe visual or auditory impairments (diplopia, low vision due to macular degeneration, retinopathy; severe hearing loss or deafness);
Cognitive and consciousness disturbances prior to ICU admission;
Severe motion sickness;
Head trauma or surgery that prevents the wearing of equipment;
Trial design
Design model
Parallel
Treatments tested in this trial
VRFS
DeviceParticipants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: VRFS InterventionExperimental treatment 1 intervention
Group B: Standard ICU CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Delirium Day
Delirium is monitored and evaluated by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU has four items ((1) altered mental status/fluctuating course, (2)inattention, (3) altered level of consciousness, and (4) disorganized thinking) and each item has two factors (positive or negative). The physicians can diagnose the patients with delirium when the results of item (1), item (2), and item (3) or item (4) are positive.
Time frame
Twice daily from Day 1 through ICU discharge, an average of 7 days.Secondary outcomes
1
ICU Days
The ICU stays are daily recorded by the physicians and nurses in ICU.
Time frame
From ICU admission through ICU discharge, an average of 7 days.2
Duration of Mechanical Ventilation
The duration of mechanical ventilation is daily recorded by the physicians and nurses.
Time frame
From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.3
Dosage of sedative and analgesic drugs
Daily records by doctors and nurses.
Time frame
Daily from Day 1 through ICU discharge, an average of 7 days.4
Incidence of Delirium
The proportion of participants who experience at least one CAM-ICU-positive episode during their ICU stay, assessed twice daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Time frame
Twice daily from Day 1 through ICU discharge, an average of 7 days.Other outcomes
1
Electroencephalogram (EEG)
A wearable headset device was utilized to obtain consistent and adequate quality EEG data.
Time frame
At baseline (Day 0) and within 3 days after ICU discharge.2
Oxygen saturation level
The oxygen saturation level (SpO2, %) will be collected from a bedside monitor before the intervention.
Time frame
At baseline (Day 0) and within 3 days after ICU discharge.3
Blood pressure
The blood pressure(mmHg) will be collected from a bedside monitor after the intervention. Both Systolic and Diastolic Blood Pressure will be measured.
Time frame
At baseline (Day 0) and within 3 days after ICU discharge.Sponsors and contacts
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Source ClinicalTrials.gov