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

NCT ID: NCT05159648

Last Updated: 2025-04-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-02

Study Completion Date

2023-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Operative Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robert (Bobby) J. Anderson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Anderson, APRN, CNP, DNP

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-008071

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PupillOmetry for Prediction of DelirIUM
NCT05248035 ACTIVE_NOT_RECRUITING