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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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Once, during ICU admission within 24 hours of ICU admission. |
| 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. | Once, immediately following the virtual reality ICU simulation session. |
| 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. | Once, up to 3 days after transfer out of the Intensive Care Unit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During ICU admission; average 2 days |
| Duration of Intravenous Sedation in the ICU |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with normal neurologic function scheduled for elective cardiothoracic surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Anderson, APRN, CNP, DNP | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Historical Control Group | Use of standard ultrasound probe for arterial line placement. |
| FG001 | Intervention Group | Use of dual-view ultrasound probe for arterial line placement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Historical Control Group | Use of standard single-view ultrasound probe for arterial line placement. |
| BG001 | Intervention Group | Use of dual-view ultrasound probe for arterial line placement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Once, during ICU admission within 24 hours of ICU admission. |
|
Adverse Events will be collected for all participants from baseline to end of study, approximately five days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Historical Control Group | Use of standard single-view ultrasound probe for arterial line placement. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Robert Anderson | Mayo Clinic | 507-284-4341 | anderson.robert2@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2022 | Dec 16, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Number of hours of intravenous sedation in the ICU measured through the medication administration record via the electronic healthcare record. |
| During ICU admission; average 2 days |
| 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. | During ICU admission; average 2 days |
| Use of Anti-psychotic Medications | Number of antipsychotic medication administrations in the ICU measured through the medication administration record via the electronic healthcare record. | Throughout ICU admission; average of 5 days |
| 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. | During OR case; average 12 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Gender information was only collected from subjects who completed the study | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Neurocognitive disorder | Count of Participants | Participants |
|
| Use of neurologic altering medication | Count of Participants | Participants |
|
| Return to operating room prior to discharge from ICU | Count of Participants | Participants |
|
Pre-operative virtual reality simulation. |
|
|
| 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. | Data was not collected nor analyzed for 68 subjects in the control group as they chose not to complete the survey. | Posted | Count of Participants | Participants | 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. The number of subjects who completed the survey. | Data was not collected nor analyzed for 68 subjects in the control group as they chose not to complete the survey. | Posted | Count of Participants | Participants | 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 measured in the electronic health record from admission time to the ICU to discharge time from the ICU. | Not Posted | During ICU admission; average 2 days | Participants |
| 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. | Not Posted | During ICU admission; average 2 days | Participants |
| 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. | Not Posted | During ICU admission; average 2 days | Participants |
| 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. | Not Posted | Throughout ICU admission; average of 5 days | 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. | Not Posted | During OR case; average 12 hours | Participants |
| 0 |
| 139 |
| 0 |
| 139 |
| 0 |
| 139 |
| EG001 | Intervention Group | Use of dual-view ultrasound probe for arterial line placement. | 0 | 95 | 0 | 95 | 0 | 95 |
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |