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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This goal of this study is to better understand when and where intraoperative transesophageal echocardiography (TEE) should (or should not) be used during coronary artery bypass graft (CABG) surgeries.
This trial will look at benefits and harms to two different treatments strategies in order to improve clinical outcomes. Intraoperative TEE is an ultrasound-based, imaging device that uses sound waves to look at the heart continuously during a heart surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Default TEE | Active Comparator | The TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of the heart before and after a CABG surgery. If randomized to this group, the TEE probe will remain in place throughout the surgery. |
|
| As-needed TEE | Other | The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEE probe | Device | Transesophageal echocardiography, ultrasound probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment and Randomization Feasibility | 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. | At time of enrollment and randomization (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol Adherence | Protocol adherence defined as receipt of the intraoperative transesophageal echocardiography strategy corresponding to randomized assignment. | During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours) |
| Rescue Echocardiography Use in the Backup TEE Arm |
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Inclusion Criteria:
Exclusion Criteria:
Documented valve (aortic, mitral, tricuspid, or pulmonic) disease (stenosis or regurgitation) moderate or greater.
Any CABG surgery with either "possible" or "definite" aortic intervention listed as a planned part of the procedure. plan for either definite or possible surgical intervention.
Any CABG surgery with either "possible" or "definite" valve repair/replacement listed as a planned part of the procedure.
Having undergone any previous cardiac surgeries (i.e. scheduled with a "REDO" modifier).
Proximal/critical left main coronary disease (e.g. greater than or equal to 90% stenosis).
Preexisting anomalous coronary arteries
Preexisting end-stage renal disease on hemodialysis
Preexisting chronic kidney disease (CKD) stage 3, 4, or 5
Stroke with residual focal neurological deficit(s) within 90 days of surgery
Any of the following presurgical, mechanical circulatory support devices:
Absolute contraindication to echocardiography defined as one or more of the following documented conditions:
Any of these three relative contraindication to TEE:
Severe pulmonary hypertension defined as:
Hemodynamic instability after induction and following placement of an endotracheal tube will be defined as one or more of the following events or scenarios:
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| Name | Affiliation | Role |
|---|---|---|
| Emily MacKay, DO, MS | University of Pennsylvania, Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Backup TEE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enrollment and Randomization Feasibility | 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. | Posted | Count of Participants | Participants | At time of enrollment and randomization (baseline) |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conversion from isolated CABG to CABG + mitral valve replacement | Cardiac disorders | Not coded | Non-systematic Assessment | Intraoperative TEE identified eccentric moderate mitral regurgitation, prompting conversion from isolated CABG to combined CABG with mitral valve replacement. Event adjudicated as related to intraoperative TEE exposure. |
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This two-hospital feasibility trial was not powered to detect differences in clinical outcomes. The small sample size and limited follow-up preclude conclusions regarding the safety or effectiveness of either arm. Findings are intended to inform the design and conduct of a larger multicenter trial. The term "Backup TEE" used in this record corresponds to the "As-needed TEE" strategy described in the IRB-approved protocol and the "TEE-on-Demand" strategy used in the manuscript.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily J. MacKay DO, MS, Assistant Professor of Anesthesiology | University of Pennsylvania | (215) 662-3751 | emily.mackay@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2024 | Feb 9, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 4, 2023 | Feb 9, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003324 | Coronary Artery Disease |
| D002637 | Chest Pain |
| D023921 | Coronary Stenosis |
| D000072657 | ST Elevation Myocardial Infarction |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D017548 | Echocardiography, Transesophageal |
| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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(1) Default TEE: Where the TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of your heart before and after the CABG surgery. The TEE probe will remain in place throughout the surgery. (2) As-Needed TEE: Where the TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.
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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. |
| During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours) |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m2 |
|
| Ejection Fraction | Mean | Standard Deviation | % |
|
| Preoperative Serum Creatinine (Cr) | Mean | Standard Deviation | mg/dL |
|
| Hypertension | Count of Participants | Participants |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Proximal Left Main Coronary Disease | Count of Participants | Participants |
|
| Non-ST-segment elevation myocardial infarction (NSTEMI) | Count of Participants | Participants |
|
| 1-2 Bypass Grafts | Count of Participants | Participants |
|
| 3 Bypass Grafts | Count of Participants | Participants |
|
| >3 Bypass Grafts | Count of Participants | Participants |
|
| Society of Thoracic Surgeons (STS) Predicted Risk of Mortality | The STS Predicted Risk of Mortality represents the model-estimated probability (expressed as a percentage) of operative mortality based on patient clinical characteristics using the Society of Thoracic Surgeons Adult Cardiac Surgery Database risk model. Higher values indicate greater predicted risk. | Mean | Standard Deviation | % predicted risk of mortality |
|
| Society of Thoracic Surgeons (STS) Predicted Risk of Morbidity or Mortality | The STS Predicted Risk of Morbidity or Mortality represents the model-estimated probability (expressed as a percentage) of major morbidity or operative mortality based on patient clinical characteristics using the Society of Thoracic Surgeons Adult Cardiac Surgery Database risk model. Higher values indicate greater predicted perioperative risk. | Mean | Standard Deviation | % predicted risk of morbidity or mortali |
|
|
| Secondary | Protocol Adherence | Protocol adherence defined as receipt of the intraoperative transesophageal echocardiography strategy corresponding to randomized assignment. | Posted | Count of Participants | Participants | During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours) |
|
|
|
| Secondary | Rescue Echocardiography Use in the Backup TEE Arm | 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. | Posted | Count of Participants | Participants | During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours) |
|
|
|
| 0 |
| 21 |
| 2 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 1 | 19 | 1 | 19 | 0 | 19 |
|
| TEE-related esophageal bleeding requiring endoscopic therapy | Gastrointestinal disorders | Not coded | Non-systematic Assessment | Esophageal bleeding following intraoperative TEE which required therapeutic endoscopic cauterization. Event adjudicated as related to intraoperative TEE exposure |
|
| Severe swallowing dysfunction requiring percutaneous gastrostomy tube placement | Gastrointestinal disorders | Not coded | Non-systematic Assessment | One participant in the Backup TEE arm received rescue TEE and developed severe postoperative swallowing dysfunction requiring percutaneous gastrostomy (PEG), complicated by aspiration pneumonia (ultimately died 185 days postoperatively). |
|
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |