Post-Operative Delirium
Conditions
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.
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Historical Control Group Use of standard single-view ultrasound probe for arterial line placement. | 139 |
| Intervention Group Use of dual-view ultrasound probe for arterial line placement. | 95 |
| Total | 234 |
Baseline characteristics
| Characteristic | Historical Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 139 Participants | 95 Participants | 234 Participants |
| Age, Continuous | 72 years | 50 years | 60 years |
| Neurocognitive disorder | 106 Participants | 95 Participants | 201 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 139 participants | 95 participants | 234 participants |
| Return to operating room prior to discharge from ICU | 135 Participants | 95 Participants | 230 Participants |
| Sex: Female, Male Female | 22 Participants | 10 Participants | 32 Participants |
| Sex: Female, Male Male | 72 Participants | 34 Participants | 106 Participants |
| Use of neurologic altering medication | 131 Participants | 95 Participants | 226 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 0 / 95 |
| other Total, other adverse events | 0 / 139 | 0 / 95 |
| serious Total, serious adverse events | 0 / 139 | 0 / 95 |
Outcome results
Primary
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.
Time frame: Once, during ICU admission within 24 hours of ICU admission.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Historical Control Group | Confusion Assessment Method for the ICU (CAM-ICU) | 4 Participants |
| Intervention Group | Confusion Assessment Method for the ICU (CAM-ICU) | 1 Participants |
Primary
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.
Time frame: Once, up to 3 days after transfer out of the Intensive Care Unit.
Population: Data was not collected nor analyzed for 68 subjects in the control group as they chose not to complete the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Historical Control Group | Subjective Experiential Outcome After ICU Admission | 26 Participants |
| Intervention Group | Subjective Experiential Outcome After ICU Admission | 44 Participants |
Primary
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.
Time frame: Once, immediately following the virtual reality ICU simulation session.
Population: Data was not collected nor analyzed for 68 subjects in the control group as they chose not to complete the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Historical Control Group | Subjective Experiential Outcome After ICU Simulation | 26 Participants |
| Intervention Group | Subjective Experiential Outcome After ICU Simulation | 44 Participants |
Secondary
Cardiopulmonary Bypass
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.
Time frame: During OR case; average 12 hours
Secondary
Duration of ICU Admission
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.
Time frame: During ICU admission; average 2 days
Secondary
Duration of Intravenous Sedation in the ICU
Number of hours of intravenous sedation in the ICU measured through the medication administration record via the electronic healthcare record.
Time frame: During ICU admission; average 2 days
Secondary
Duration of Mechanical Ventilation in the ICU
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.
Time frame: During ICU admission; average 2 days
Secondary
Use of Anti-psychotic Medications
Number of antipsychotic medication administrations in the ICU measured through the medication administration record via the electronic healthcare record.
Time frame: Throughout ICU admission; average of 5 days