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EVENT - Evaluation of the Influence of hTEE

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02046954
Acronym
EVENT
Enrollment
36
Registered
2014-01-28
Start date
2012-10-31
Completion date
2013-07-31
Last updated
2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Heart Insufficiency

Keywords

transesophageal echocardiography, tee, toe, cardiac surgery

Brief summary

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).

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cumulative dosage of catecholamine applicationthree days beginning upon placement of device

Secondary

MeasureTime frameDescription
fluid balanceday 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
degree and duration of lactate acidosisdegree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)maximum lactate level, date/time of maximum lactate level, first date/time when lactate \<20
duration of postoperative ventilationfirst postoperative day until extubation (2 days on average)
incidence of renal failurethree days beginning upon placement of device (or icu admission in control patients, respectively)analysis of creatinine plasma level
degree and duration of other vasoactive substancesdegree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)i.e. epinephrine, levosimendan, dopamine, nitroglycerine, nitroprusside
length of hospital stayparticipants will be followed for the duration of hospital stay, an expected average of 3 weeks
in-hospital mortalityparticipants will be followed for the duration of hospital stay, an expected average of 3 weeks
cost of hospital stayparticipants will be followed for the duration of hospital stay, an expected average of 3 weeks
incidence of hemodialysisthree days beginning upon placement of device (or icu admission in control patients, respectively)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026