Post-Operative DeliriumNCT05159648
A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium
An observational study of Post-Operative Delirium, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-Operative Delirium
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 20 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with normal neurologic function scheduled for elective cardiothoracic surgery.
Who may be able to join
- Baseline normal neurological function pre-operatively.
- Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pre-operative, Multi-sensory ICU Simulation Experience to Reduce Post-operative Delirium in the Cardiothoracic Surgical Population
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.
- Conditions
- Post-Operative Delirium
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Once, up to 3 days after transfer out of the Intensive Care Unit.
Secondary outcomes (5)
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.
Measured: During ICU admission; average 2 days
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During OR case; average 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start2 Dec 2021
- Primary completion1 Jun 2022
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Operative DeliriumStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert (Bobby) J. Anderson, Mayo Clinic
- Investigators
- Robert Anderson, APRN, CNP, DNP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159648
- Sponsor's protocol ID
- 19-008071
- Status last verified
- Mar 2025
- First submitted
- 13 Oct 2021
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative, Multi-sensory ICU Simulation Experience to Reduce Post-operative Delirium in the Cardiothoracic Surgical Population
- ClinicalTrials.gov ID
- NCT05159648
- Acronym / sponsor ID
- 19-008071
- Conditions
- Post-Operative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with normal neurologic function scheduled for elective cardiothoracic surgery.
Key inclusion criteria (2 listed)
- Baseline normal neurological function pre-operatively.
- Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
5 secondary outcomes
Duration of ICU Admission
Time frame: During ICU admission; average 2 days
Duration of Intravenous Sedation in the ICU
Time frame: During ICU admission; average 2 days
Duration of Mechanical Ventilation in the ICU
Time frame: During ICU admission; average 2 days
Use of Anti-psychotic Medications
Time frame: Throughout ICU admission; average of 5 days
Cardiopulmonary Bypass
Time frame: During OR case; average 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Anderson, APRN, CNP, DNP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Operative Delirium, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confusion Assessment Method for the ICU (CAM-ICU) (time frame: Once, during ICU admission within 24 hours of ICU admission.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.