VR Interventions to Reduce the Prevalence of Delirium in ICU Patients

NCT05525702 | Recruiting DMC

• 1 other identifier: K4774
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium

Keywords

ICU; Virtual Reality; Delirium; family support

Outcome Measures

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.

  Twice daily from Day 1 through ICU discharge, an average of 7 days.

Secondary Outcomes (5)

• ICU Days

  From ICU admission through ICU discharge, an average of 7 days.

• Duration of Mechanical Ventilation

  From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.

• Dosage of sedative and analgesic drugs

  Daily from Day 1 through ICU discharge, an average of 7 days.

• Incidence of Delirium

  Twice daily from Day 1 through ICU discharge, an average of 7 days.

• Family Satisfaction with Care in the Intensive Care Unit (FS-ICU)

  At baseline (Day 0) and within 3 days after ICU discharge.

Other Outcomes (3)

• Electroencephalogram (EEG)

  At baseline (Day 0) and within 3 days after ICU discharge.

• Oxygen saturation level

  At baseline (Day 0) and within 3 days after ICU discharge.

• Blood pressure

  At baseline (Day 0) and within 3 days after ICU discharge.

Study Arms (2)

VRFS Intervention

EXPERIMENTAL

Participants will receive standard ICU care and will also undergo VRFS intervention.

Device: VRFS

Standard ICU Care

NO INTERVENTION

Patients will be treated with standard ICU care and not receive VR stimulation.

Interventions

VRFS DEVICE

Participants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort.

VRFS Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

PUMC

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (13)

• Nassar Junior AP, Besen BAMP, Robinson CC, Falavigna M, Teixeira C, Rosa RG. Flexible Versus Restrictive Visiting Policies in ICUs: A Systematic Review and Meta-Analysis. Crit Care Med. 2018 Jul;46(7):1175-1180. doi: 10.1097/CCM.0000000000003155.

  PMID: 29642108 BACKGROUND

• da Silva Ramos FJ, Fumis RR, Azevedo LC, Schettino G. Perceptions of an open visitation policy by intensive care unit workers. Ann Intensive Care. 2013 Oct 17;3(1):34. doi: 10.1186/2110-5820-3-34.

  PMID: 24135292 BACKGROUND

• Mohsen S, Moss SJ, Lucini F, Krewulak KD, Stelfox HT, Niven DJ, Sauro KM, Fiest KM. Impact of Family Presence on Delirium in Critically Ill Patients: A Retrospective Cohort Study. Crit Care Med. 2022 Nov 1;50(11):1628-1637. doi: 10.1097/CCM.0000000000005657. Epub 2022 Aug 26.

  PMID: 36044306 BACKGROUND

• Deng LX, Cao L, Zhang LN, Peng XB, Zhang L. Non-pharmacological interventions to reduce the incidence and duration of delirium in critically ill patients: A systematic review and network meta-analysis. J Crit Care. 2020 Dec;60:241-248. doi: 10.1016/j.jcrc.2020.08.019. Epub 2020 Aug 31.

  PMID: 32919363 BACKGROUND

• Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

  PMID: 24088092 BACKGROUND

• van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1097/CCM.0b013e31822e9fc9.

  PMID: 21926597 BACKGROUND

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 BACKGROUND

• Mehta S, Cook D, Devlin JW, Skrobik Y, Meade M, Fergusson D, Herridge M, Steinberg M, Granton J, Ferguson N, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Mallick R, Reynolds S, Keenan S, Burry L; SLEAP Investigators; Canadian Critical Care Trials Group. Prevalence, risk factors, and outcomes of delirium in mechanically ventilated adults. Crit Care Med. 2015 Mar;43(3):557-66. doi: 10.1097/CCM.0000000000000727.

  PMID: 25493968 BACKGROUND

• Wiegand TLT, Remi J, Dimitriadis K. Electroencephalography in delirium assessment: a scoping review. BMC Neurol. 2022 Mar 11;22(1):86. doi: 10.1186/s12883-022-02557-w.

  PMID: 35277128 BACKGROUND

• Salluh JI, Soares M, Teles JM, Ceraso D, Raimondi N, Nava VS, Blasquez P, Ugarte S, Ibanez-Guzman C, Centeno JV, Laca M, Grecco G, Jimenez E, Arias-Rivera S, Duenas C, Rocha MG; Delirium Epidemiology in Critical Care Study Group. Delirium epidemiology in critical care (DECCA): an international study. Crit Care. 2010;14(6):R210. doi: 10.1186/cc9333. Epub 2010 Nov 23.

  PMID: 21092264 BACKGROUND

• Janssen TL, Alberts AR, Hooft L, Mattace-Raso F, Mosk CA, van der Laan L. Prevention of postoperative delirium in elderly patients planned for elective surgery: systematic review and meta-analysis. Clin Interv Aging. 2019 Jun 19;14:1095-1117. doi: 10.2147/CIA.S201323. eCollection 2019.

  PMID: 31354253 BACKGROUND

• Chen H, Mo L, Hu H, Ou Y, Luo J. Risk factors of postoperative delirium after cardiac surgery: a meta-analysis. J Cardiothorac Surg. 2021 Apr 26;16(1):113. doi: 10.1186/s13019-021-01496-w.

  PMID: 33902644 BACKGROUND

• Thom RP, Levy-Carrick NC, Bui M, Silbersweig D. Delirium. Am J Psychiatry. 2019 Oct 1;176(10):785-793. doi: 10.1176/appi.ajp.2018.18070893. No abstract available.

  PMID: 31569986 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yun Long, MD

  Peking Union Medical College

  STUDY DIRECTOR

Central Study Contacts

Yingying Yang, MD

CONTACT

+8618800173833; yangyingying2703@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the VR intervention, blinding of participants and care providers is not feasible. Outcome assessors (nurses responsible for delirium assessment using CAM-ICU) are blinded to group allocation and are not involved in the delivery of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: September 1, 2022
• Study Start: December 18, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)