VR Interventions to Reduce the Prevalence of Delirium in ICU Patients

Not Applicable

Recruiting

• Conditions: Delirium
• Interventions: Device: Virtual Reality Treatment

• Registration Number: NCT05525702
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Study Start: 2023-12-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-30
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR Stimulation	Virtual Reality Treatment	Patients wear head-mounted displays and experience high immersive virtual environments for treatment.

Primary Outcome Measures

Name	Time	Method
Delirium Day	2 years	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.

Secondary Outcome Measures

Name	Time	Method
ICU Days	2 years	The ICU stays are daily recorded by the physicians and nurses in ICU.
Duration of Mechanical Ventilation	2 years	The duration of mechanical ventilation is daily recorded by the physicians and nurses.
Electroencephalogram (EEG)	2 years	A wearable headset device was utilized to obtain consistent and adequate quality EEG data.
Oxygen saturation level	2 years	The oxygen saturation level (SpO2, %) will be collected from a bedside monitor before the intervention.
Blood pressure	2 years	The blood pressure(mmHg) will be collected from a bedside monitor after the intervention. Both Systolic and Diastolic Blood Pressure will be measured.
Dosage of sedative and analgesic drugs	2 years	Daily records by doctors and nurses.

Trial Locations

Locations (1)

PUMC; 🇨🇳 Beijing, Beijing, China