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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Delirium Day [Time frame: Twice daily from Day 1 through ICU discharge, an average of 7 days.]

Secondary outcome measures (5)

• ICU Days [Time frame: From ICU admission through ICU discharge, an average of 7 days.]
• Duration of Mechanical Ventilation [Time frame: From the start of mechanical ventilation through endotracheal tube (ETT) removal, an average of 6 days.]
• Dosage of sedative and analgesic drugs [Time frame: Daily from Day 1 through ICU discharge, an average of 7 days.]
• Incidence of Delirium [Time frame: Twice daily from Day 1 through ICU discharge, an average of 7 days.]
• Family Satisfaction with Care in the Intensive Care Unit (FS-ICU) [Time frame: At baseline (Day 0) and within 3 days after ICU discharge.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• PUMC — Beijing

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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: 10.1 PMID 25493968

Identifiers

NCT: NCT05525702 · K4774

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗