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Completed

NCT Number: NCT05159648

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Confusion Assessment Method for the ICU (CAM-ICU)

    Time frame: 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.

  2. Subjective Experiential Outcome After ICU Simulation

    Time frame: 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.

  3. Subjective Experiential Outcome After ICU Admission

    Time frame: 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.

Secondary outcomes

  1. Duration of ICU Admission

    Time frame: 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.

  2. Duration of Intravenous Sedation in the ICU

    Time frame: 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.

  3. Duration of Mechanical Ventilation in the ICU

    Time frame: 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.

  4. Use of Anti-psychotic Medications

    Time frame: 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.

  5. Cardiopulmonary Bypass

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 16, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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