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

Pre-operative, Multi-sensory ICU Simulation Experience to Reduce Post-operative Delirium in the Cardiothoracic Surgical Population

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.

Study Overview

• Status: Completed
• Conditions: Post-Operative Delirium

• Study Type: Observational
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with normal neurologic function scheduled for elective cardiothoracic surgery.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confusion Assessment Method for the ICU (CAM-ICU)	Number of Participants with one or more Positive Confusion Assessment. "Confusion Assessment Method for the ICU" - Establishes ability to detect delirium in high-risk settings such as the intensive care unit. Recorded during every scheduled patient assessment by nurse and with mental changes. Reports as "Positive" or "Negative" with response to different assessments regarding level of consciousness, acute onset or fluctuating course of mental status and inattention.	Once, during ICU admission within 24 hours of ICU admission.
Subjective Experiential Outcome After ICU Simulation	Survey questions to understand patient's subjective experience during the virtual reality ICU simulation session. Internally created survey. The number of subjects who completed the survey.	Once, immediately following the virtual reality ICU simulation session.
Subjective Experiential Outcome After ICU Admission	Survey questions to understand patient's subjective experience in the intensive care unit. The number of subjects who completed the survey.	Once, up to 3 days after transfer out of the Intensive Care Unit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of ICU Admission	Number of hours in the intensive care unit measured in the electronic health record from admission time to the ICU to discharge time from the ICU.	During ICU admission; average 2 days
Duration of Intravenous Sedation in the ICU	Number of hours of intravenous sedation in the ICU measured through the medication administration record via the electronic healthcare record.	During ICU admission; average 2 days
Duration of Mechanical Ventilation in the ICU	Number of hours of mechanical ventilation in the ICU measured via the electronic healthcare record with data imported into the electronic healthcare record directly from the mechanical ventilator.	During ICU admission; average 2 days
Use of Anti-psychotic Medications	Number of antipsychotic medication administrations in the ICU measured through the medication administration record via the electronic healthcare record.	Throughout ICU admission; average of 5 days
Cardiopulmonary Bypass	Number of hours of use of cardiopulmonary bypass in the operating room via record from the cardiopulmonary bypass perfusionist in the operating room imported into the electronic healthcare record.	During OR case; average 12 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Robert Anderson, APRN, CNP, DNP, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): August 20, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium
• Other Study ID Numbers: 19-008071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No