Observational Prospective Transesophageal Myocardial Ultrasound Survey
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- Mortality and Morbidity
研究概览
简要总结
The gold standard in hemodynamic evaluation has been the combined use of echocardiography and right heart catheterization. Fall backs to echocardiography are its time consumption and requirement for specialist interpretation while the Swan-Ganz® catheter shows a poor correlation of central venous pressure to volume status and provides indirect and difficult to interpret measurements in patients with unique pathophysiological states.
Next generation continuous hemodynamic transesophageal echocardiography (hTEE®) is being increasingly utilized to assist with complex resuscitations and to monitor the hemodynamic profiles of critically ill patients. hTEE is proving to be an essential diagnostic, therapeutic and monitoring tool for the rapid evaluation of the hemodynamic state in the critically ill patient and or hemodynamically compromised patient.
The purpose of this observational study is to evaluate the role of hTEE in clinical decision-making in 30 patients recruited from OR-Trauma and in 30 patients from the Cardiovascular-OR. Hemodynamic trans-esophageal echocardiography (hTEE) incorporates an FDA-approved miniaturized, disposable probe for continuous use in patients for up to 72 hours. This device has been used for postoperative assessment in the ICU for several years with successful placement of probes and without any adverse incidents.
The probe allows for the rapid, intermittent or continuous evaluation of bi-ventricular function, volume status and valve function at bedside or intraoperatively. It also allows for the evaluation of pericardial effusions and or the exclusion of pericardial tamponade.
详细描述
The device can evaluate trans-valvular flow as well as valvular regurgitation with the use of the color flow function. In many situations hTEE enables imaging not feasible by transthoracic echocardiography due to wounds, dressings, lines or edema.
The hTEE does not provide the visual acuity and detail of formal TEE, but it has the advantage of requiring a significantly smaller probe (hence the decreased risk of possible injury) with the ability of providing rapid, repeatable and sequential assessment by caregivers intraoperatively or at the bedside.
Data will be reviewed for outcome measures comparing efficiency, accuracy and clinical decision making capability of the FDA approved hTEE cardiac monitoring system vs. the standard of care Swan-Ganz/ echocardiographic information for publication. The ultimate goal will be to demonstrate whether or not after implementation of probes in surgical trauma and CVICU patients, there is a difference in:
- Mortality and Morbidity
- Organ dysfunction and failure
- Blood product administration
- Length of ICU stay
- Hospital stay
2. Study Design and Statistical Procedures This is a two phase, single center, non-blinded, non-randomized, observational and retrospective study to be carried out at Memorial Hermann Hospital. The data from the hTEE study group will be compared to the control group (in-house OR-Trauma and CV surgery databases) and will be analyzed on a patient to patient basis for its impact on clinical decision-making.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• All study subjects 18 to 85 years old.
- •OR-Trauma patients Presenting w/ hemodynamic instability. W/ expected intubation greater than 24 hours.
- •CVICU patients (Cardiovascular Intensive Care Unit) Requiring non-isolated cardiac and vascular surgery
排除标准
- •Current or previous esophageal injury
结局指标
主要结局
Mortality and Morbidity
时间窗: 30 days
Comparing 30 day mortality and morbidity
次要结局
- Organ dysfunction and failure(30 days)
- Length of ICU stay(30 days)
- Hospital stay(30 days)
- Blood product administration(48 hours)
研究者
yafen liang
Professor
The University of Texas Health Science Center, Houston