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

Completed

• Conditions: Post-Operative Delirium

• Registration Number: NCT05159648
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-13
• Study Start: 2021-12-02
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-16
• Primary Completion: 2022-06-01
• Status Verified: 2023-08
• Study Completion: 2023-08-20
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Baseline normal neurological function pre-operatively.
• Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAM-ICU	Once, during ICU admission within 24 hours of ICU admission.	"Confusion Assessment Method for the ICU" - Metric of delirium in the intensive care unit.
Subjective experiential outcome after ICU simulation	Once, immediately following the virtual reality ICU simulation session.	Survey questions to understand patient's subjective experience during the virtual reality ICU simulation session.
Subjective experiential outcome after ICU admission	Once, up to 3 days after transfer out of the Intensive Care Unit.	Survey questions to understand patient's subjective experience in the intensive care unit.

Secondary Outcome Measures

Name	Time	Method
Cardiopulmonary Bypass	During OR case; average 12 hours	Number of hours of use of cardiopulmonary bypass in the operating room
Use of anti-psychotic medications	Throughout ICU admission; average of 5 days	Number of administrations of anti-psychotic medications in the ICU
Duration of ICU admission	During ICU admission; average 2 days	Number of hours in the intensive care unit
Duration of mechanical ventilation in the ICU	During ICU admission; average 2 days	Number of hours of mechanical ventilation in the ICU
Duration of intravenous sedation in the ICU	During ICU admission; average 2 days	Number of hours of intravenous sedation in the ICU

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States