Clinical trial NCT02046954: EVENT - Evaluation of the Influence of hTEE
Official title: Retrospective Matched Pair Analyses for Evaluating the Influence of Hemodynamically Focussed Transesophageal Echocardiography (hTEE) on Postoperative Outcome in Cardiosurgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Heart Insufficiency
Keywords: transesophageal echocardiography
tee
toe
cardiac surgery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital

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).


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative dosage of catecholamine application
timeFrame: three days beginning upon placement of device
Secondary outcomes:
measure: degree and duration of other vasoactive substances
timeFrame: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
measure: fluid balance
timeFrame: day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
measure: degree and duration of lactate acidosis
timeFrame: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
measure: duration of postoperative ventilation
timeFrame: first postoperative day until extubation (2 days on average)
measure: incidence of renal failure
timeFrame: three days beginning upon placement of device (or icu admission in control patients, respectively)
measure: incidence of hemodialysis
timeFrame: three days beginning upon placement of device (or icu admission in control patients, respectively)
measure: length of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: in-hospital mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: cost of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berin
Study officials:
References:
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