Clinical trial NCT05525702: VR Interventions to Reduce the Prevalence of Delirium in ICU Patients
Official title: Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients with Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Keywords: ICU
Virtual Reality
Delirium
family support
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn the effect of VR-based 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.

Detailed description: During the VRFS interventions, researchers will fit participants with a VR headset and noise-canceling headphones, shielding them from the ICU environment while allowing family members to be present and offer companionship and comfort.

Eligibility criteria: Inclusion Criteria

* 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. Exclusion Criteria
* 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;
* A history of long-term use of antipsychotic and/or benzodiazepine medications.

Primary outcomes:
measure: Delirium Day
timeFrame: 2 years
Secondary outcomes:
measure: ICU Days
timeFrame: 2 years
measure: Duration of Mechanical Ventilation
timeFrame: 2 years
measure: Electroencephalogram (EEG)
timeFrame: 2 years
measure: Oxygen saturation level
timeFrame: 2 years
measure: Blood pressure
timeFrame: 2 years
measure: Dosage of sedative and analgesic drugs
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: PUMC
state: Beijing
Study officials:
affiliation: Peking Union Medical College
name: Yun Long, MD
role: STUDY_DIRECTOR
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