Trial Outcomes & Findings for A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium (NCT NCT05159648)
NCT ID: NCT05159648
Last Updated: 2025-04-08
Results Overview
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.
COMPLETED
234 participants
Once, during ICU admission within 24 hours of ICU admission.
2025-04-08
Participant Flow
Participant milestones
| Measure |
Historical Control Group
Use of standard ultrasound probe for arterial line placement.
|
Intervention Group
Use of dual-view ultrasound probe for arterial line placement.
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
95
|
|
Overall Study
COMPLETED
|
94
|
44
|
|
Overall Study
NOT COMPLETED
|
45
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender information was only collected from subjects who completed the study
Baseline characteristics by cohort
| Measure |
Historical Control Group
n=139 Participants
Use of standard single-view ultrasound probe for arterial line placement.
|
Intervention Group
n=95 Participants
Use of dual-view ultrasound probe for arterial line placement.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=139 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=234 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
139 Participants
n=139 Participants
|
95 Participants
n=95 Participants
|
234 Participants
n=234 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=139 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=234 Participants
|
|
Age, Continuous
|
72 years
n=139 Participants
|
50 years
n=95 Participants
|
60 years
n=234 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=94 Participants • Gender information was only collected from subjects who completed the study
|
10 Participants
n=44 Participants • Gender information was only collected from subjects who completed the study
|
32 Participants
n=138 Participants • Gender information was only collected from subjects who completed the study
|
|
Sex: Female, Male
Male
|
72 Participants
n=94 Participants • Gender information was only collected from subjects who completed the study
|
34 Participants
n=44 Participants • Gender information was only collected from subjects who completed the study
|
106 Participants
n=138 Participants • Gender information was only collected from subjects who completed the study
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
139 participants
n=139 Participants
|
95 participants
n=95 Participants
|
234 participants
n=234 Participants
|
|
Neurocognitive disorder
|
106 Participants
n=139 Participants
|
95 Participants
n=95 Participants
|
201 Participants
n=234 Participants
|
|
Use of neurologic altering medication
|
131 Participants
n=139 Participants
|
95 Participants
n=95 Participants
|
226 Participants
n=234 Participants
|
|
Return to operating room prior to discharge from ICU
|
135 Participants
n=139 Participants
|
95 Participants
n=95 Participants
|
230 Participants
n=234 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Historical Control Group
n=94 Participants
Routine post operative intensive care unit care.
|
Intervention Group
n=44 Participants
Pre-operative virtual reality simulation.
|
|---|---|---|
|
Confusion Assessment Method for the ICU (CAM-ICU)
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Historical Control Group
n=94 Participants
Routine post operative intensive care unit care.
|
Intervention Group
n=44 Participants
Pre-operative virtual reality simulation.
|
|---|---|---|
|
Subjective Experiential Outcome After ICU Simulation
|
26 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: 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.
Survey questions to understand patient's subjective experience in the intensive care unit. The number of subjects who completed the survey.
Outcome measures
| Measure |
Historical Control Group
n=94 Participants
Routine post operative intensive care unit care.
|
Intervention Group
n=44 Participants
Pre-operative virtual reality simulation.
|
|---|---|---|
|
Subjective Experiential Outcome After ICU Admission
|
26 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: During ICU admission; average 2 daysNumber 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During ICU admission; average 2 daysNumber of hours of intravenous sedation in the ICU measured through the medication administration record via the electronic healthcare record.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During ICU admission; average 2 daysNumber 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout ICU admission; average of 5 daysNumber of antipsychotic medication administrations in the ICU measured through the medication administration record via the electronic healthcare record.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During OR case; average 12 hoursNumber 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.
Outcome measures
Outcome data not reported
Adverse Events
Historical Control Group
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place