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

NCT05159648 | Completed Results

• 1 other identifier: 19-008071
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Operative Delirium

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Duration of ICU Admission

  During ICU admission; average 2 days

• Duration of Intravenous Sedation in the ICU

  During ICU admission; average 2 days

• Duration of Mechanical Ventilation in the ICU

  During ICU admission; average 2 days

• Use of Anti-psychotic Medications

  Throughout ICU admission; average of 5 days

• Cardiopulmonary Bypass

  During OR case; average 12 hours

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with normal neurologic function scheduled for elective cardiothoracic surgery.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Robert Anderson
• Organization: Mayo Clinic

anderson.robert2@mayo.edu

507-284-4341

Study Officials

• Robert Anderson, APRN, CNP, DNP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 16, 2021
• Study Start: December 2, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 20, 2023
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-03

Locations

US (1)