A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- Baseline normal neurological function pre-operatively.
- Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. The number of subjects who completed the survey.
Confusion Assessment Method for the ICU (CAM-ICU) Once, during ICU admission within 24 hours of ICU admission. 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.
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. Internally created survey. The number of subjects who completed the survey.
- Secondary Outcome Measures
Name Time Method Duration of ICU Admission During ICU admission; average 2 days 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.
Duration of Intravenous Sedation in the ICU During ICU admission; average 2 days Number of hours of intravenous sedation in the ICU measured through the medication administration record via the electronic healthcare record.
Duration of Mechanical Ventilation in the ICU During ICU admission; average 2 days 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.
Use of Anti-psychotic Medications Throughout ICU admission; average of 5 days Number of antipsychotic medication administrations in the ICU measured through the medication administration record via the electronic healthcare record.
Cardiopulmonary Bypass During OR case; average 12 hours 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.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States