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临床试验/NCT02046954
NCT02046954已完成不适用

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

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Cumulative dosage of catecholamine application

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • pregnant/breastfeeding women

结局指标

主要结局

Cumulative dosage of catecholamine application

时间窗: three days beginning upon placement of device

次要结局

  • duration of postoperative ventilation(first postoperative day until extubation (2 days on average))
  • incidence of renal failure(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)
  • degree and duration of other vasoactive substances(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(degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Sander

Univ.-Prof. Dr. med.

Charite University, Berlin, Germany

研究点 (1)

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