Pre-operative, Multi-sensory ICU Simulation Experience to Reduce Post-operative Delirium in the Cardiothoracic Surgical Population
Conditions: Post-Operative Delirium
Sponsor: Mayo Clinic

 
 
Pre-operative multi-sensory ICU simulation 
experience to reduce post-operative delirium in 
the cardiothoracic surgical population 
 
NCT05159648 
 
2/16/2022 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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General Study Information 
 
Principal Investigator:   Robert Anderson APRN, DNP, CNP     
 
 
 
 
 
 
 
 
Study Title:    Pre-operative multi-sensory ICU simulation experience to reduce post-operative delirium in the 
cardiothoracic surgical population 
 
Protocol version number and date:    V.1. 08192019 
 
Research Question and Aims 
 
Hypothesis: A pre-ICU simulation session will decrease the incidence and severity of post-operative delirium in 
the ICU after an elective cardiothoracic surgical procedure. 
 
Aims, purpose, or objectives: The purpose of this project is to evaluate the effect of a pre-ICU admission 
simulation session on post-operative delirium in the elective cardiothoracic surgical population,  
 
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):   
 
Cardiothoracic patients are at a high risk for post-operative delirium in the intensive care unit (ICU). 
Approximately 50% of patients admitted to the intensive care unit develop or are impacted by some form of 
acute delirium. This can lead to a three-fold increase in 6-month mortality, increased time on the mechanical 
ventilator, elongated hospital length of stay, and nearly 50% of those patients affected having a cognitive 
impairment at hospital discharge some with long term cognitive impairment (approximately 1 in 3 patients). 
Specifically, delirium incidence in the post-cardiac surgery population is between 26-52%. Delirium in this 
population specifically has been associated with increased mortality, stroke risk, hospital readmission and 
cognitive dysfunction as well as poorer functional status.  
 
The literature supports the use of pre-operative educational experiences as a mechanism to reduce delirium 
incidence.  
 
The initial phase of this project is to identify the baseline rate of delirium in the cardiothoracic surgical intensive 
care unit. Anecdotal data from practitioners in this unit indicate that post-operative delirium across “surgical 
procedure types” is a strong concern. A primary gap in this population’s care is that our institution does not 
have a program in place to prepare patients for the experience they will have admitted to the ICU post-
operatively. 
 
The initial phase of this project will include baseline data collection over a period of 3 months to determine 
current delirium rates (CAM-ICU) and other ICU outcome metrics including ventilator time, use of sedatives 
and antipsychotics, restraint use rates, and ICU and hospital length of stay. 
 
Following initial baseline data collection, the intervention will be to provide a pre-cardiothoracic surgery patient 
a multi-sensory pre-recorded virtual reality ICU simulation experience to introduce them to the senses they can 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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expect to encounter post-operatively when admitted to the critical care unit. This is intended as a mechanism to 
reduce post-operative delirium in this population by allowing them to “become familiar” with the 
sights/sounds/tactile experiences in the ICU so that they are not completely foreign to the patient upon 
admission post-operatively. 
 
 
Study Design and Methods 
 
Methods:  Describe in lay terms, completely detailing the research activities that will be conducted by Mayo 
Clinic staff under this protocol. 
 
Data collection and Outcome Metrics : 
• CAM-ICU scores in the post-operative setting 
• Incidence of acute delirium in the post-operative setting 
• Time of intravenous sedation in the post-operative setting 
• Time of mechanical ventilator in the post-operative setting 
• Incidence of anti-psychotic medication administration to treat delirium 
• Incidence and duration of cardiopulmonary bypass “pump time” 
• Metrics will be stratified based on type of operative procedure, operative time, age, gender, necessity 
for return to operating room prior to initial extubation 
The data source will be the electronic medical record. Baseline retrospective data will be collected on patients 
prior recorded prior to the start date of this IRB submission; prospective patients undergoing simulation session 
will have data recorded post IRB start date. Data collection form attached with IRB submission. 
 
Charts of all initial post cardiac surgery patients admitted directly to the ICU who meet the above criteria will 
be reviewed. 
 
Pre ICU Simulation Survey – Patient 
1. You are going to be admitted to the intensive care unit after your surgery. What are your thoughts / 
feelings / fears regarding your upcoming ICU stay? 
 
Post-ICU Simulation, intervention patients will be surveyed with the following questions: 
1.  What was the biggest take-home point you learned during your virtual reality ICU simulation 
experience? 
2. How do you hope that this ICU simulation experience will impact your actual ICU experience after your 
cardiac surgery? 
 
Post actual ICU experience, intervention patients will be surveyed in person with the following questions: 
 
1. Please describe your ICU experience. 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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2. What do you remember from your virtual reality pre-operative ICU simulation experience? 
3. Did you experience any of the things you experienced in the virtual reality ICU simulation during your 
actual ICU experience? Please describe. 
4. How do you feel that your pre-operative virtual reality ICU simulation experience impacted your or 
prepared you for your actual ICU experience? 
5. Did you feel that the pre-operative virtual reality ICU simulation experience was beneficial? 
6. What about your actual ICU experience was unfamiliar to you? 
7. How would you modify the pre-operative virtual reality ICU simulation experience to improve your 
actual ICU experience? 
 
 
Informed consent for research will be obtained by a member of the research team in the pre-surgical clinic 
setting; a future date for the simulation session will then be mutually agreed upon by study staff and 
patient/family. 
 
Following informed consent for research, the pre-surgical patient will be asked to view a 10 minutes pre-
recorded virtual reality simulation session from the perspective of a postoperative ICU patient.  This virtual 
reality simulation session has been recorded in the Mayo Clinic Simulation Center under the guidance of study 
team members from Critical Care, and Cardiothoracic surgery. 
 
 
The multi-sensory ICU simulation experience will include the following: 
• View on a virtual reality head set 
• Introduce to different care team members 
• Introduction to common equipment found in the patient room in the intensive care unit 
• Introduction to common experiences, sounds, sights and procedures in the intensive care unit 
• Total video duration:  10 minutes 
Subject Information 
 
Target accrual is the proposed total number of subjects to be included in this study at Mayo Clinic. A “Subject” 
may include medical records, images, or specimens generated at Mayo Clinic and/or received from external 
sources.    
 
Target accrual: 50 historic patients for baseline metric; 50 current intervention patients to undergo simulation 
session. 
 
 
Subject population (children, adults, groups):  Adult 
 
Inclusion Criteria: Baseline normal neurological function pre-operatively, planned use of mechanical ventilator 
with endotracheal tube post-operatively after planned cardiothoracic surgical procedure. Age: greater 
than 18 and less than 60.  
 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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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. Age greater than 60; Age less than 18. Previous admission to an intensive care unit 
(intervention patients). 
 
 
Review of medical records, images, specimens  
 
  The study involves data that exist at the time of IRB submission and data that will be generated after IRB 
submission. Include this activity in the Methods section.  
Examples 
• The study plans to conduct a retrospective chart review and ask subjects to complete a questionnaire.  
• The study plans to include subjects previously diagnosed with a specific disease and add newly 
diagnosed subjects in the future.  
_______________________________ 
Data Analysis 
 
 
Power analyses may not be appropriate if this is a feasibility or pilot study, but end-point analysis plans are 
always appropriate even if only exploratory. Provide all information requested below, or provide justification if 
not including all of the information.  
 
Power Statement:  Based on the literature indicating incidence of post-operative delirium in the post 
cardiothoracic surgical population and initial power analysis calculations, initial calculations indicate sample 
size of approximately 30 patients. Therefore, to accommodate for patient loss to follow-up will aim for sample 
size of 50 patients. 
 
 
Data Analysis Plan: A comparative analysis of the outcome metrics described in the “Study Design and 
Methods” section will be completed between the pre-implementation baseline data and the post-implementation 
intervention data. This analysis will evaluate the effect of the multi-sensory ICU simulation experience on post-
operative delirium in the cardiac surgical population. An additional post-implementation interview/survey will 
be conducted on post-intervention patients as described above. 
 
 
 
Endpoints 
Primary: Study to end when sample sizes are obtained. 
Secondary: None.