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 range18 Years – 60 Years

SexALL

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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.

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