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

Post-Operative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05159648
• Other study ID #: 19-008071
• Status: Completed
• Start date: December 2, 2021
• Est. completion date: August 20, 2023

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 20, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Post-Operative Delirium

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAM-ICU	"Confusion Assessment Method for the ICU" - Metric of delirium in the intensive care unit.	Once, during ICU admission within 24 hours of ICU admission.
Primary	Subjective experiential outcome after ICU simulation	Survey questions to understand patient's subjective experience during the virtual reality ICU simulation session.	Once, immediately following the virtual reality ICU simulation session.
Primary	Subjective experiential outcome after ICU admission	Survey questions to understand patient's subjective experience in the intensive care unit.	Once, up to 3 days after transfer out of the Intensive Care Unit.
Secondary	Duration of ICU admission	Number of hours in the intensive care unit	During ICU admission; average 2 days
Secondary	Duration of intravenous sedation in the ICU	Number of hours of intravenous sedation in the ICU	During ICU admission; average 2 days
Secondary	Duration of mechanical ventilation in the ICU	Number of hours of mechanical ventilation in the ICU	During ICU admission; average 2 days
Secondary	Use of anti-psychotic medications	Number of administrations of anti-psychotic medications in the ICU	Throughout ICU admission; average of 5 days
Secondary	Cardiopulmonary Bypass	Number of hours of use of cardiopulmonary bypass in the operating room	During OR case; average 12 hours

External Links

•   Mayo Clinic Clinical Trials