CompletedNot Applicable

A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium

United States234 participantsStarted 2021-12-02

Plain-language summary

The purpose of this study is to evaluate the effect of a pre-ICU admission virtual reality ICU simulation on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Baseline normal neurological function pre-operatively. * Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure. Exclusion Criteria: * Chronic dementia, Alzheimer's disease, or other chronic neurological disease (i.e., Bi-Polar). * Chronic use of neurological altering medications such as benzodiazepines, psychotropic, anti-depressants, anxiolytics. * Patient undergoing emergent surgery. * Use of post-operative cardiopulmonary support devices such as ECMO (extracorporeal membrane oxygenation), intra-aortic balloon pump, total artificial heart, or other similar device.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Confusion Assessment Method for the ICU (CAM-ICU)

Timeframe: Once, during ICU admission within 24 hours of ICU admission.

Subjective Experiential Outcome After ICU Simulation

Timeframe: Once, immediately following the virtual reality ICU simulation session.

Subjective Experiential Outcome After ICU Admission

Timeframe: Once, up to 3 days after transfer out of the Intensive Care Unit.

Trial details

NCT IDNCT05159648

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-01

Results submitted2024-05-01

View on ClinicalTrials.gov More Post-Operative Delirium trials