EVENT - Evaluation of the Influence of hTEE

Study Overview
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Brief Summary
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Compromised tissue oxygenation during surgery may negatively influence patient outcome. Primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia and/or reduced cardiac contractility. In cardiac surgery patients especially, postoperative pericardia effusion and/or tamponade may further compromise cardiac function. Today, hemodynamically instable patients are often monitored by means of pulmonal artery catheters or transpulmonary thermodilution. However, these methods only allow quantification of functional limitations. Underlying causes may be investigated by relatively recent technology through hemodynamically focussed transesophageal echocardiography (ClariTEE(R) ImaCor) that also provide the possibility of continuous monitoring. It has been reported that a training program consisting of six hours may enable physicians who are unexperienced in the field of echocardiography to apply this new method. Up to now, there is no evidence whether this methods is associated with improved postoperative outcome. Therefore we hypothesize that continuous hemodynamically focussed transesophageal echocardiography positively influences patient outcome (primary hypothesis). Furthermore, its application may decrease hospital expenses (secondary hypothesis).

Official Title
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Retrospective Matched Pair Analyses for Evaluating the Influence of Hemodynamically Focussed Transesophageal Echocardiography (hTEE) on Postoperative Outcome in Cardiosurgery Patients

Conditions
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Postoperative Heart Insufficiency

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective, cardiac surgery hemodynamic instability or placement of hTEE/PICCO (Pulse Contour Continuous Cardiac Output) /PAC (Pulmonary Arterial Catheter) within 12 hours of ICU admission Exclusion Criteria: pregnant/breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients monitored with hemodynamically focussed transesophageal echocardiography (placement within 12 hours of ICU admission) | |
| Control Group<br>Patients receiving conventional monitoring (e.g. transpulmonary thermodilution) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative dosage of catecholamine application |  | three days beginning upon placement of device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree and duration of other vasoactive substances | i.e. epinephrine, levosimendan, dopamine, nitroglycerine, nitroprusside | degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively) | 
| fluid balance |  | day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively) | 
| degree and duration of lactate acidosis | maximum lactate level, date/time of maximum lactate level, first date/time when lactate <20 | degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively) | 
| duration of postoperative ventilation |  | first postoperative day until extubation (2 days on average) | 
| incidence of renal failure | analysis of creatinine plasma level | three days beginning upon placement of device (or icu admission in control patients, respectively) | 
| incidence of hemodialysis |  | three days beginning upon placement of device (or icu admission in control patients, respectively) | 
| length of hospital stay |  | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 
| in-hospital mortality |  | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 
| cost of hospital stay |  | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transesophageal echocardiography, tee, toe, cardiac surgery