Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-01-10 @ 2:52 PM
Study NCT ID:
NCT05525702
Status:
RECRUITING
Last Update Posted:
2024-12-30
First Post:
2022-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR Interventions to Reduce the Prevalence of Delirium in ICU Patients
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
Effects of Multi-model Virtual Reality Intervention Method to Reduce the Prevalence of Delirium in ICU Patients with Mechanical Ventilation
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
·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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: