Trial Outcomes & Findings for Intraoperative Echocardiography in Low-Risk CABG Surgery (NCT NCT06154265)
NCT ID: NCT06154265
Last Updated: 2026-05-12
Results Overview
Enrollment and randomization feasibility defined as the proportion of patients approached for enrollment who consented and were successfully randomized. Of 72 patients approached for enrollment, 40 were randomized.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
At time of enrollment and randomization (baseline)
Results posted on
2026-05-12
Participant Flow
Participant milestones
| Measure |
Default TEE
Participants randomized to routine intraoperative transesophageal echocardiography (TEE). A TEE probe was placed after induction of anesthesia and imaging was performed throughout surgery according to standard practice.
|
Backup TEE
Participants randomized to backup intraoperative transesophageal echocardiography (TEE). A TEE probe and imaging system were immediately available but TEE was performed only if clinically indicated at the discretion of the care team.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Echocardiography in Low-Risk CABG Surgery
Baseline characteristics by cohort
| Measure |
Default TEE
n=20 Participants
Participants randomized to routine intraoperative transesophageal echocardiography (TEE). A TEE probe was placed after induction of anesthesia and imaging was performed throughout surgery according to standard practice.
|
Backup TEE
n=20 Participants
Participants randomized to backup intraoperative transesophageal echocardiography (TEE). A TEE probe and imaging system were immediately available but TEE was performed only if clinically indicated at the discretion of the care team.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Age, Continuous
|
67.40 years
STANDARD_DEVIATION 9.07 • n=1512 Participants
|
63.45 years
STANDARD_DEVIATION 9.34 • n=504 Participants
|
65.42 years
STANDARD_DEVIATION 9.30 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=1512 Participants
|
17 Participants
n=504 Participants
|
35 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=1512 Participants
|
15 Participants
n=504 Participants
|
33 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=1512 Participants
|
18 Participants
n=504 Participants
|
36 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=1512 Participants
|
20 Participants
n=504 Participants
|
40 Participants
n=2016 Participants
|
|
Body Mass Index (BMI)
|
33.38 Kg/m2
STANDARD_DEVIATION 6.53 • n=1512 Participants
|
29.44 Kg/m2
STANDARD_DEVIATION 5.28 • n=504 Participants
|
31.41 Kg/m2
STANDARD_DEVIATION 6.19 • n=2016 Participants
|
|
Ejection Fraction
|
59.16 %
STANDARD_DEVIATION 6.40 • n=1512 Participants
|
60.15 %
STANDARD_DEVIATION 6.51 • n=504 Participants
|
59.67 %
STANDARD_DEVIATION 6.39 • n=2016 Participants
|
|
Preoperative Serum Creatinine (Cr)
|
1.04 mg/dL
STANDARD_DEVIATION 0.19 • n=1512 Participants
|
0.98 mg/dL
STANDARD_DEVIATION 0.23 • n=504 Participants
|
1.01 mg/dL
STANDARD_DEVIATION 0.21 • n=2016 Participants
|
|
Hypertension
|
18 Participants
n=1512 Participants
|
16 Participants
n=504 Participants
|
34 Participants
n=2016 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Proximal Left Main Coronary Disease
|
9 Participants
n=1512 Participants
|
9 Participants
n=504 Participants
|
18 Participants
n=2016 Participants
|
|
Non-ST-segment elevation myocardial infarction (NSTEMI)
|
4 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
10 Participants
n=2016 Participants
|
|
1-2 Bypass Grafts
|
3 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
3 Bypass Grafts
|
10 Participants
n=1512 Participants
|
12 Participants
n=504 Participants
|
22 Participants
n=2016 Participants
|
|
>3 Bypass Grafts
|
7 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
13 Participants
n=2016 Participants
|
|
Society of Thoracic Surgeons (STS) Predicted Risk of Mortality
|
1.46 % predicted risk of mortality
STANDARD_DEVIATION 2.02 • n=1512 Participants
|
0.95 % predicted risk of mortality
STANDARD_DEVIATION 1.06 • n=504 Participants
|
1.20 % predicted risk of mortality
STANDARD_DEVIATION 1.61 • n=2016 Participants
|
|
Society of Thoracic Surgeons (STS) Predicted Risk of Morbidity or Mortality
|
7.23 % predicted risk of morbidity or mortali
STANDARD_DEVIATION 8.69 • n=1512 Participants
|
5.04 % predicted risk of morbidity or mortali
STANDARD_DEVIATION 2.84 • n=504 Participants
|
6.14 % predicted risk of morbidity or mortali
STANDARD_DEVIATION 6.47 • n=2016 Participants
|
PRIMARY outcome
Timeframe: At time of enrollment and randomization (baseline)Enrollment and randomization feasibility defined as the proportion of patients approached for enrollment who consented and were successfully randomized. Of 72 patients approached for enrollment, 40 were randomized.
Outcome measures
| Measure |
Backup TEE
n=72 Participants
Participants randomized to backup intraoperative transesophageal echocardiography (TEE). A TEE probe and imaging system were immediately available but TEE was performed only if clinically indicated at the discretion of the care team.
|
Default TEE
Participants randomized to routine intraoperative transesophageal echocardiography (TEE). A TEE probe was placed after induction of anesthesia and imaging was performed throughout surgery according to standard practice.
|
|---|---|---|
|
Enrollment and Randomization Feasibility
|
40 Participants
|
—
|
SECONDARY outcome
Timeframe: During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)Protocol adherence defined as receipt of the intraoperative transesophageal echocardiography strategy corresponding to randomized assignment.
Outcome measures
| Measure |
Backup TEE
n=20 Participants
Participants randomized to backup intraoperative transesophageal echocardiography (TEE). A TEE probe and imaging system were immediately available but TEE was performed only if clinically indicated at the discretion of the care team.
|
Default TEE
n=20 Participants
Participants randomized to routine intraoperative transesophageal echocardiography (TEE). A TEE probe was placed after induction of anesthesia and imaging was performed throughout surgery according to standard practice.
|
|---|---|---|
|
Protocol Adherence
|
19 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)Use of rescue transesophageal echocardiography among participants randomized to the Backup TEE strategy, defined as intraoperative TEE performed in response to a clinical indication per protocol. Of 20 participants randomized to Backup TEE, 3 (15%) received rescue TEE.
Outcome measures
| Measure |
Backup TEE
n=20 Participants
Participants randomized to backup intraoperative transesophageal echocardiography (TEE). A TEE probe and imaging system were immediately available but TEE was performed only if clinically indicated at the discretion of the care team.
|
Default TEE
Participants randomized to routine intraoperative transesophageal echocardiography (TEE). A TEE probe was placed after induction of anesthesia and imaging was performed throughout surgery according to standard practice.
|
|---|---|---|
|
Rescue Echocardiography Use in the Backup TEE Arm
|
3 Participants
|
—
|
Adverse Events
Default TEE
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Backup TEE
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Default TEE
n=21 participants at risk
Participants randomized to routine intraoperative transesophageal echocardiography (TEE). A TEE probe was placed after induction of anesthesia and imaging was performed throughout surgery according to standard practice.
|
Backup TEE
n=19 participants at risk
Participants randomized to backup intraoperative transesophageal echocardiography (TEE). A TEE probe and imaging system were immediately available but TEE was performed only if clinically indicated at the discretion of the care team.
|
|---|---|---|
|
Cardiac disorders
Conversion from isolated CABG to CABG + mitral valve replacement
|
4.8%
1/21 • From index procedure through last available follow-up, including events occurring beyond the planned 90-day postoperative period (up to 185 days)
Adverse events were prospectively collected during the intraoperative period and postoperative follow-up and reviewed by an independent Data and Safety Monitoring Board. Adverse events are reported according to the intervention actually received. One participant randomized to the Backup TEE arm received Default TEE due to inadvertent misallocation. One death occurred 185 days postoperatively in the Backup TEE group and is included in the All-Cause Mortality table.
|
0.00%
0/19 • From index procedure through last available follow-up, including events occurring beyond the planned 90-day postoperative period (up to 185 days)
Adverse events were prospectively collected during the intraoperative period and postoperative follow-up and reviewed by an independent Data and Safety Monitoring Board. Adverse events are reported according to the intervention actually received. One participant randomized to the Backup TEE arm received Default TEE due to inadvertent misallocation. One death occurred 185 days postoperatively in the Backup TEE group and is included in the All-Cause Mortality table.
|
|
Gastrointestinal disorders
TEE-related esophageal bleeding requiring endoscopic therapy
|
4.8%
1/21 • From index procedure through last available follow-up, including events occurring beyond the planned 90-day postoperative period (up to 185 days)
Adverse events were prospectively collected during the intraoperative period and postoperative follow-up and reviewed by an independent Data and Safety Monitoring Board. Adverse events are reported according to the intervention actually received. One participant randomized to the Backup TEE arm received Default TEE due to inadvertent misallocation. One death occurred 185 days postoperatively in the Backup TEE group and is included in the All-Cause Mortality table.
|
0.00%
0/19 • From index procedure through last available follow-up, including events occurring beyond the planned 90-day postoperative period (up to 185 days)
Adverse events were prospectively collected during the intraoperative period and postoperative follow-up and reviewed by an independent Data and Safety Monitoring Board. Adverse events are reported according to the intervention actually received. One participant randomized to the Backup TEE arm received Default TEE due to inadvertent misallocation. One death occurred 185 days postoperatively in the Backup TEE group and is included in the All-Cause Mortality table.
|
|
Gastrointestinal disorders
Severe swallowing dysfunction requiring percutaneous gastrostomy tube placement
|
0.00%
0/21 • From index procedure through last available follow-up, including events occurring beyond the planned 90-day postoperative period (up to 185 days)
Adverse events were prospectively collected during the intraoperative period and postoperative follow-up and reviewed by an independent Data and Safety Monitoring Board. Adverse events are reported according to the intervention actually received. One participant randomized to the Backup TEE arm received Default TEE due to inadvertent misallocation. One death occurred 185 days postoperatively in the Backup TEE group and is included in the All-Cause Mortality table.
|
5.3%
1/19 • From index procedure through last available follow-up, including events occurring beyond the planned 90-day postoperative period (up to 185 days)
Adverse events were prospectively collected during the intraoperative period and postoperative follow-up and reviewed by an independent Data and Safety Monitoring Board. Adverse events are reported according to the intervention actually received. One participant randomized to the Backup TEE arm received Default TEE due to inadvertent misallocation. One death occurred 185 days postoperatively in the Backup TEE group and is included in the All-Cause Mortality table.
|
Other adverse events
Adverse event data not reported
Additional Information
Emily J. MacKay DO, MS, Assistant Professor of Anesthesiology
University of Pennsylvania
Phone: (215) 662-3751
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place