Evaluation of Three Dimensional Echocardiography in Critical Care Medicine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution
研究概览
简要总结
Comparison of volumetric measurements obtained by three dimensional echocardiography with measurements obtained by thermodilution using a pulmonary artery catheter in the intensive care unit.
详细描述
Prospective, observational study evaluating three dimensional echocardiography for measuring hemodynamic variables versus the current gold standard (pulmonary artery catheter).
Critically ill patients with a severly compromised circulation due to a shock state with an advanced hemodynamic monitoring in place and the need for echocardiographic evaluation will be included.
While performing an echocardiography study stroke volume measurements using the bolus method for thermodilution will concomittantly be measured.
In case of insufficient image quality we are planning to use SonoVue echo contrast. Once the image quality has improved we will repeat the stroke volume measurements with the bolus thermodilution method while performing the echocardiography.
The acquired echocardiography loops will then be analysed and measured offline once deferred consent has been obtained. We will then compare the echocardiographic measurements with the measurement obtained by the pulmonary artery catheter (bolus method) - since this is the current reference method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced hemodynamic monitoring with pulmonary artery catheter and arterial catheter in place
- •patient intubated or tracheostomy in place
- •clinical indication for performing an echocardiography
- •ongoing sedation requirement
排除标准
- •Heart rhythm other than sinus rhythm or paced atrial rhythm
- •Known allergy to sulphur-hexafluoride (SonoVue©)
- •Artificial heart valves in place
- •Any form of mechanical cardiac assist
- •contraindication to performing a transesophageal echocardiography
- •presence of significant cardiac valve regurgitation
- •presence of an intracardiac shunt
结局指标
主要结局
Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution
时间窗: through study completion, an average of 1 year
The stroke volume of three to six heart beats will be measured after having performed an echocardiographic study. The stroke volume by thermodilution will be measured during the individual examination.
次要结局
- Feasibility of right ventricular pressure volume loops(through study completion, an average of 1 year)