N/A
Completed N=234
A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium
Post-Operative Delirium
Source: ClinicalTrials.gov NCT05159648 ↗
Enrolled (actual)
234
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Confusion Assessment Method for the ICU (CAM-ICU) — 4; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confusion Assessment Method for the ICU (CAM-ICU) |
4; 1 | — |
| PRIMARY Subjective Experiential Outcome After ICU Simulation |
26; 44 | — |
| PRIMARY Subjective Experiential Outcome After ICU Admission |
26; 44 | — |
| SECONDARY Duration of ICU Admission |
— | — |
| SECONDARY Duration of Intravenous Sedation in the ICU |
— | — |
| SECONDARY Duration of Mechanical Ventilation in the ICU |
— | — |
| SECONDARY Use of Anti-psychotic Medications |
— | — |
| SECONDARY Cardiopulmonary Bypass |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05159648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.