Cardiovascular Risk FactorsEGHEMNCT01050361
Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery
A study testing Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE) in people with Cardiovascular Risk Factors, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2010to 9 Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 65 years
- Hypertension (HTN)
- Diabetes
- Obesity (body mass index [BMI] >35)
- Renal insufficiency
- Tobacco usage
Show all 25Show fewer
- 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
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Inability of give informed consent
- Participation in another clinical trial
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Echocardiography-Guided Hemodynamic Management Strategy for Patients Requiring Perioperative Care for Non-Cardiac Surgery
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.
Read the detailed description
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:
- Urology/gynecology/General surgical patient
- Non-cardiac surgical population
- age 65 years or older, OR 19 years or older and one of the following risk factors:
- Hypertension (HTN)
- Diabetes
- Obesity (body mass index [BMI] >35)
- Renal insufficiency
- Tobacco usage
- Hypercholesterolemia
- Sleep apnea/heavy snoring at night
- 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
- 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) Standard Medical Care Step 2: Pre-op assessment
Step 2 in the EGAM process involves a bedside, transthoracic echocardiography (TTE) pre-op assessment. The pre-op TTE should be performed by one of the co-investigators, and take less than 10 minutes to complete. The information acquired by TTE during the pre-op assessment should include the following five evaluations, in order of importance:
- Cardiac output on the left side of the heart using spectral Doppler measurements;
- Left ventricular outflow tract (LVOT) velocity time integral (VTI)
- Heart rate
- Filling pressures on the left side of the heart using spectral Doppler measurements;
- The pulmonary venous flow pattern defined as co-dominant, systolic dominant or diastolic dominant
- The mitral inflow pattern defined as normal, impaired relaxation, pseudonormal or restrictive
- The E/e' ratio of velocities
- Mitral valve structure and function;
- Aortic valve structure and function; and
- Biventricular contractility.
These evaluations are performed using the following TTE views:
- Parasternal (PS) window: With the patient in the left lateral decubitus position, the TTE probe is placed on the 3rd left intercostal space next to the sternum; the light on the probe should be directed toward the patient's right shoulder. The 2-dimensional image of the long axis (LAX) should be acquired first. In this view, the following are evaluated:
- Color Doppler on aortic valve (AV) and mitral valve (MV)
- E-point septal separation (EPSS) To evaluate the PS short axis (SAX), the probe should be rotated clockwise 60 degrees. The 2-dimensional view should be obtained at the mid-papillary level.
- Apical window: With the patient in the same left, lateral, decubitus position, the probe is placed between the 5th and 6th intercostal space on the left side, close to the nipple line. The light on the probe should be directed toward the floor or the bed for the 4-chamber view. The following assessments should be performed in the 4-chamber view:
- Two-dimensional image;
- Pulsed-wave (PW) Doppler in the right upper pulmonary vein;
- PW Doppler at the tip of the MV;
- PW Doppler on the MV annulus for tissue Doppler;
- Color Doppler on the tricuspid valve (TV) and MV if necessary based on the PS LAX window.
For the apical LAX, the probe should be rotated counterclockwise so that the light is directed toward the patient's right shoulder. In the LAX view, velocity time integrals (VTIs) using PW in the left ventricular outflow track (LVOT) and continuous wave (CW) at the level of the AV should be acquired.
- Subcostal window: With the patient supine, the TTE probe is placed under the right costal ridge and directed toward the heart. The light should be directed toward the sonographer (toward the patient's left) to assess the 4-chamber view.
For the subcostal inferior vena cava (IVC) view, the probe should be slightly rotated counterclockwise until the IVC can be assessed.
Standard Medical Care Step 3: Management strategies Step 3 in the EGHEM/EGAM process is to define patient management strategies based on the pre-op TTE assessment. The main goals of patient management are to maintain normal cardiac output and filling pressure. Primary and secondary findings and the associated EGAM strategies to achieve these goals are outlined in Table 1 and Table 2, respectively.
Table 1: Primary findings and associated management strategy to maintain normal cardiac output and filling pressure.
Echo-Generated Findings EGHEM/EGAM Strategy Cardiac output status Filling pressure status Normal High Preload reduction Low Normal Afterload reduction Low High Afterload and preload reduction High High Preload reduction High Normal or low Increase preload
Table 2: Secondary findings and associated management strategy to optimize patient management.
Echo-Generated Finding EGHEM/EGAM Strategy Filling Pressure Other High Aortic stenosis Preload reduction Normal Aortic stenosis Safe for afterload reduction
- Mitral regurgitation Afterload reduction
- Low contractility Inotropic support
- Suspected or confirmed CAD Maintain heart rate in the 50 - 60 bpm range right ventricle (RV) volume overload Preload reduction RV pressure overload Pulmonary afterload reduction Standard Medical Care Step 4: Ongoing intra-operative assessment Based on the appropriate EGAM strategy defined in Step 3, either TEE or TTE should be used during the surgical procedure for the ongoing patient assessment every 15 to 20 minutes. The PI or Secondary Investigator will determine whether a TEE or TTE should be conducted intra-operatively. The results of these tests will be used for research purposes. During surgery: fluid administration, afterload adjustments, and supported contractility can be implemented to optimize patient management. It is difficult to assess cardiac output with the current standard medical care without invasive monitoring. There is minimal risk if the physician gets distracted by the echocardiogram or the algorithm of the study however it is unlikely this tool would be a distraction to the physician as it is monitoring the patient.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)
- Keywords
- congestive heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)Procedure or surgery
Duration lasts the entire operation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 years
Reducing perioperative mortality in congestive heart failure for non-cardiac surgeries
Perioperative mortality associated with congestive heart failure for non-cardiac surgeries.
Measured: 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.
Measured: 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.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study start28 Jul 2010
- Primary completion9 Jan 2013
- Study completion9 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara R Brakke, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050361
- Sponsor's protocol ID
- 0321-09-FB
- Acronym
- EGHEM
- Status last verified
- Dec 2023
- First submitted
- 13 Jan 2010
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography-Guided Hemodynamic Management Strategy for Patients Requiring Perioperative Care for Non-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01050361
- Acronym / sponsor ID
- EGHEM / 0321-09-FB
- Conditions
- Cardiovascular Risk Factors
- Keywords
- congestive heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 28 Jul 2010 (actual)
- Primary completion
- 9 Jan 2013 (actual)
- Study completion
- 9 Jan 2013 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Urology/gynecology/General surgical patient
- Non-cardiac surgical population
- age 65 years or older, OR 19 years or older and one of the following risk factors:
- Hypertension (HTN)
- Diabetes
- Obesity (body mass index [BMI] >35)
- Renal insufficiency
- Tobacco usage
- Hypercholesterolemia
- Sleep apnea/heavy snoring at night
- 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
- 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) Standard Medical Care Step 2: Pre-op assessment
Step 2 in the EGAM process involves a bedside, transthoracic echocardiography (TTE) pre-op assessment. The pre-op TTE should be performed by one of the co-investigators, and take less than 10 minutes to complete. The information acquired by TTE during the pre-op assessment should include the following five evaluations, in order of importance:
- Cardiac output on the left side of the heart using spectral Doppler measurements;
- Left ventricular outflow tract (LVOT) velocity time integral (VTI)
- Heart rate
- Filling pressures on the left side of the heart using spectral Doppler measurements;
- The pulmonary venous flow pattern defined as co-dominant, systolic dominant or diastolic dominant
- The mitral inflow pattern defined as normal, impaired relaxation, pseudonormal or restrictive
- The E/e' ratio of velocities
- Mitral valve structure and function;
- Aortic valve structure and function; and
- Biventricular contractility.
These evaluations are performed using the following TTE views:
- Parasternal (PS) window: With the patient in the left lateral decubitus position, the TTE probe is placed on the 3rd left intercostal space next to the sternum; the light on the probe should be directed toward the patient's right shoulder. The 2-dimensional image of the long axis (LAX) should be acquired first. In this view, the following are evaluated:
- Color Doppler on aortic valve (AV) and mitral valve (MV)
- E-point septal separation (EPSS) To evaluate the PS short axis (SAX), the probe should be rotated clockwise 60 degrees. The 2-dimensional view should be obtained at the mid-papillary level.
- Apical window: With the patient in the same left, lateral, decubitus position, the probe is placed between the 5th and 6th intercostal space on the left side, close to the nipple line. The light on the probe should be directed toward the floor or the bed for the 4-chamber view. The following assessments should be performed in the 4-chamber view:
- Two-dimensional image;
- Pulsed-wave (PW) Doppler in the right upper pulmonary vein;
- PW Doppler at the tip of the MV;
- PW Doppler on the MV annulus for tissue Doppler;
- Color Doppler on the tricuspid valve (TV) and MV if necessary based on the PS LAX window.
For the apical LAX, the probe should be rotated counterclockwise so that the light is directed toward the patient's right shoulder. In the LAX view, velocity time integrals (VTIs) using PW in the left ventricular outflow track (LVOT) and continuous wave (CW) at the level of the AV should be acquired.
- Subcostal window: With the patient supine, the TTE probe is placed under the right costal ridge and directed toward the heart. The light should be directed toward the sonographer (toward the patient's left) to assess the 4-chamber view.
For the subcostal inferior vena cava (IVC) view, the probe should be slightly rotated counterclockwise until the IVC can be assessed.
Standard Medical Care Step 3: Management strategies Step 3 in the EGHEM/EGAM process is to define patient management strategies based on the pre-op TTE assessment. The main goals of patient management are to maintain normal cardiac output and filling pressure. Primary and secondary findings and the associated EGAM strategies to achieve these goals are outlined in Table 1 and Table 2, respectively.
Table 1: Primary findings and associated management strategy to maintain normal cardiac output and filling pressure.
Echo-Generated Findings EGHEM/EGAM Strategy Cardiac output status Filling pressure status Normal High Preload reduction Low Normal Afterload reduction Low High Afterload and preload reduction High High Preload reduction High Normal or low Increase preload
Table 2: Secondary findings and associated management strategy to optimize patient management.
Echo-Generated Finding EGHEM/EGAM Strategy Filling Pressure Other High Aortic stenosis Preload reduction Normal Aortic stenosis Safe for afterload reduction
- Mitral regurgitation Afterload reduction
- Low contractility Inotropic support
- Suspected or confirmed CAD Maintain heart rate in the 50 - 60 bpm range right ventricle (RV) volume overload Preload reduction RV pressure overload Pulmonary afterload reduction Standard Medical Care Step 4: Ongoing intra-operative assessment Based on the appropriate EGAM strategy defined in Step 3, either TEE or TTE should be used during the surgical procedure for the ongoing patient assessment every 15 to 20 minutes. The PI or Secondary Investigator will determine whether a TEE or TTE should be conducted intra-operatively. The results of these tests will be used for research purposes. During surgery: fluid administration, afterload adjustments, and supported contractility can be implemented to optimize patient management. It is difficult to assess cardiac output with the current standard medical care without invasive monitoring. There is minimal risk if the physician gets distracted by the echocardiogram or the algorithm of the study however it is unlikely this tool would be a distraction to the physician as it is monitoring the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echo Guided HEmodyanmic Management (EGHEM) | Experimental | Procedure: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)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. |
| 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). |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Age ≥ 65 years
- Hypertension (HTN)
- Diabetes
- Obesity (body mass index [BMI] >35)
- Renal insufficiency
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)Duration lasts the entire operation. | Procedure or surgery | Echo Guided HEmodyanmic Management (EGHEM) |
Primary outcome
Optimizing participant perioperative hemodynamic management (cardiac ultrasound)
Time frame: 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
Time frame: 3 years
Incidence of perioperative morbidity associated with congestive heart failure for non-cardiac surgeries.
Evaluate echocardiography technology for identifying participant perioperative hemodynamic management needs
Time frame: 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.
Reducing perioperative mortality in congestive heart failure for non-cardiac surgeries
Time frame: 3 years
Perioperative mortality associated with congestive heart failure for non-cardiac surgeries.
Optimizing participant perioperative hemodynamic management (systemic blood pressure)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara R Brakke, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE) in people with Cardiovascular Risk Factors, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimizing participant perioperative hemodynamic management (cardiac ultrasound) (time frame: 3 Years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.