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临床试验/NCT01050361
NCT01050361已完成不适用

Echocardiography-Guided Hemodynamic Management Strategy for Patients Requiring Perioperative Care for Non-Cardiac Surgery

University of Nebraska2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2010年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Evaluate echocardiography technology for identifying participant perioperative hemodynamic management needs

研究概览

简要总结

The growing population of institution patients with heart failure combined with the increasing number of surgical procedures performed each year supports the need for a critical analysis of how to most appropriately manage these patients during the perioperative period, especially for non-cardiac surgery. Echo-guided hemodynamic management (EGHEM) is the use of echocardiography data to normalize and/or optimize in real-time, cardiac output and ventricular filling pressures in the perioperative period for non-cardiac surgical cases. The purpose of this study is to test the hypothesis that EGHEM compared to standard management practices will result in a reduced length of hospital stay in the noncardiac surgery population. The primary goal of health care providers for patients requiring anesthetic care, perioperative care, or critical care is ensuring the adequacy of the patient's circulatory function by optimizing cardiac output and ventricular filling pressure. Currently, the use of the ECG monitor and systemic blood pressure are the standard of care for assessing circulatory function. However, those data cannot provide accurate information on cardiac output and ventricular filling pressure for patients with cardiovascular risk factors and/or comorbidities. As a result, managing the hemodynamic parameters of these patients, as well as their intravenous fluid needs and resuscitation strategy, we hypothesize that using traditional approaches may lead to significant volume overload and post-operative cardiovascular complications and morbidity. In this study we propose an EGHEM strategy that incorporates standard echocardiography generated data points in addition to the systemic blood pressure and ECG signal to assess, manage, modify and optimize patient cardiac preload, afterload, heart rate and contractility in the perioperative period. Based on our initial observations and preliminary data using the EGHEM approach, we hypothesize that we can demonstrate a significant decrease in hospital length of stay and an overall decrease in perioperative morbidity at 30 days in the non-cardiac surgery population using EGHEM compared to standard practices. In this proposal we have designed a single center, prospective, randomized clinical trial to test our hypothesis.

详细描述

Step 1: Patient selection

The first step in the EGHEM/EGAM process is appropriate patient selection. Patients who have any of the following cardiovascular risk factors and/or comorbidities and are scheduled for a non-cardiac surgery are candidates for EGHEM/EGAM:

  1. Urology/gynecology/General surgical patient

  2. Non-cardiac surgical population

  3. age 65 years or older, OR 19 years or older and one of the following risk factors:

  4. Hypertension (HTN)

  5. Diabetes

  6. Obesity (body mass index [BMI] >35)

  7. Renal insufficiency

  8. Tobacco usage

  9. Hypercholesterolemia

  10. Sleep apnea/heavy snoring at night

  11. Clinical diagnosis of congestive heart failure (CHF) as defined by:

  • Dyspnea on exertion
  • Paroxysmal nocturnal dyspnea
  • Orthopnea
  • Elevated jugular venous pressure
  • Pulmonary rales
  • Third heart sound
  • Cardiomegaly or pulmonary edema on chest x-ray
  • Peripheral edema
  • Hepatomegaly
  • Pleural effusion
  1. Palpitations/irregular heart beats
  2. Chest pain at rest and or exercise
  3. Murmur on examination
  4. Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG)
  5. Known valvular disease
  6. Known stroke or transient ischemic attacks (TIA) Standard Medical Care Step 2: Pre-op assessment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
19 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 65 years
  • Hypertension (HTN)
  • Obesity (body mass index [BMI] >35)
  • Renal insufficiency
  • Tobacco usage
  • Hypercholesterolemia
  • Sleep apnea/heavy snoring at night
  • Clinical diagnosis of CHF as defined by:
  • Dyspnea on exertion
  • Paroxysmal nocturnal dyspnea
  • Elevated jugular venous pressure
  • Pulmonary rales
  • Third heart sound
  • Cardiomegaly or pulmonary edema on chest x-ray
  • Peripheral edema
  • Hepatomegaly
  • Pleural effusion
  • Palpitations/irregular heart beats
  • Chest pain at rest and or exercise
  • Murmur on examination
  • Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG)
  • Known valvular disease
  • Known stroke or transient ischemic attacks (TIA)

排除标准

  • Patients expected to say in the hospital for less than 24 hours.
  • Inability of undergo TEE and TTE
  • Clinical evidence or suspicion of elevated intracranial pressure.
  • Preoperative shock or systemic sepsis
  • Emergency Operation
  • American Society of Anesthesiologists (ASA) Class V
  • Inability of give informed consent
  • Participation in another clinical trial

结局指标

主要结局

Evaluate echocardiography technology for identifying participant perioperative hemodynamic management needs

时间窗: 3 years

To evaluate and support the conclusion that echocardiography is a superior technology for identifying these changes and managing the unique cardiovascular challenges of the patient population.

Optimizing participant perioperative hemodynamic management (cardiac ultrasound)

时间窗: 3 Years

Obtain standard cardiac ultrasound-generated data points \[Parasternal Long Axis, Parasternal Short Axis, Apical 4 Chamber, Subxiphoid (Subcostal), and inferior vena cava (IVC) views\] to manage, modify, and optimize the participant cardiac preload, afterload, heart rate and contractility in the perioperative period.

Perioperative morbidity in congestive heart failure for non-cardiac surgeries

时间窗: 3 years

Incidence of perioperative morbidity associated with congestive heart failure for non-cardiac surgeries.

Reducing perioperative mortality in congestive heart failure for non-cardiac surgeries

时间窗: 3 years

Perioperative mortality associated with congestive heart failure for non-cardiac surgeries.

Optimizing participant perioperative hemodynamic management (systemic blood pressure)

时间窗: 3 Years

Obtain standard systemic blood pressure (normal: systolic pressure of less than 120 and a diastolic pressure of less than 80, elevated: systolic pressure between 120 and 129 with a diastolic pressure of less than 80) to manage, modify, and optimize the participant cardiac preload, afterload, heart rate and contractility in the perioperative period.

Optimizing participant perioperative hemodynamic management electrocardiogram (ECG signal)

时间窗: 3 Years

Obtain standard electrocardiogram (ECG: normal values defined as follows: P-wave axis 0° to 75°, QRS axis -30° to 90°, and T axis 15° to 75) to manage, modify, and optimize the participant cardiac preload, afterload, heart rate and contractility in the perioperative period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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