Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery

NCT01050361 | Completed DMC

• 1 other identifier: 0321-09-FB
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Risk Factors

Keywords

congestive heart failure

Outcome Measures

Primary Outcomes (6)

• Optimizing participant perioperative hemodynamic management (cardiac ultrasound)

  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.

  3 Years

• Perioperative morbidity in congestive heart failure for non-cardiac surgeries

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

  3 years

• Evaluate echocardiography technology for identifying participant perioperative hemodynamic management needs

  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.

  3 years

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

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

  3 years

• Optimizing participant perioperative hemodynamic management (systemic blood pressure)

  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.

  3 Years

• Optimizing participant perioperative hemodynamic management electrocardiogram (ECG signal)

  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.

  3 Years

Study Arms (2)

Echo Guided HEmodyanmic Management (EGHEM)

EXPERIMENTAL

EGHEM - Echo Guided HEmodyanmic Management - will receive their intraoperative maintenance fluid and possible drug therapy (furosemide) based on their hourly intraoperative Left Ventricular Diastolic Dysfunction (LVDD) grade.

Procedure: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)

Standard HEmodynamic Management (SHEM)

NO INTERVENTION

SHEM - Standard HEmodynamic Management - will NOT receive the study intervention, but will receive standard anesthesia and hemodynamic management based on current standards within the institution (control group).

Interventions

Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE) PROCEDURE

Duration lasts the entire operation.

Echo Guided HEmodyanmic Management (EGHEM)

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Hypertension (HTN)
• Diabetes
• 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
• Orthopnea
• Elevated jugular venous pressure
• Pulmonary rales
• Third heart sound

You may not qualify if:

• 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
• Prisoner

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tara R Brakke, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: July 28, 2010
• Primary Completion: January 9, 2013
• Study Completion: January 9, 2013
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

US (1)