VR Interventions to Reduce the Prevalence of Delirium in ICU Patients
NCT ID: NCT05525702
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
102 participants
INTERVENTIONAL
2023-12-18
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
·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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VRFS Intervention
Participants will receive standard ICU care and will also undergo VRFS intervention.
VRFS
Participants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort.
Standard ICU Care
Patients will be treated with standard ICU care and not receive VR stimulation.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VRFS
Participants wear VR headsets and experience immersive virtual environments, where their family members will be present and offer companionship and comfort.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ICU stay duration is expected to be greater than 72 hours;
* Age is 18 years or older, with no upper age limit;
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking Union Medical College Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yun Long, MD
Role: STUDY_DIRECTOR
Peking Union Medical College
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PUMC
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yingying Yang, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
K4774
Identifier Type: -
Identifier Source: org_study_id