Cardiac DiseaseNCT03349970
Cardiac Output Measurement by TEE
An observational study of Cardiac Disease, run by University Health Network, Toronto at 2 sites in 2 countries.
Trial summary
Transesophageal echocardiography (TEE) has become a standard monitoring tool during cardiac surgery. It allows continuous accurate assessment of heart structures and function without interfering with the surgery and the anesthetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2017to 1 Dec 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac patients undergoing elective CABG, AV or aortic surgery (aortic root and ascending aortic arch surgery), with CPB
Who may be able to join
- age >18
- undergoing elective CABG, AV or aortic surgery (aortic root and ascending aortic arch surgery), with CPB.
Who cannot join
- Emergency surgery
- Moderate or severe valve pathology
- Atrial fibrillation
- Patients with known contraindications to either the insertion of a PAC or the use of TEE.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Intraoperative Measurement of Cardiac Output During Cardiac Surgery: Which TEE Method is Best?
Transesophageal echocardiography (TEE) has become a standard monitoring tool during cardiac surgery. It allows continuous accurate assessment of heart structures and function without interfering with the surgery and the anesthetics. The imaging of cardiac structures is used to direct optimal surgical intervention and assess surgical results. Cardiac output (CO) is the result of stroke volume (SV) multiplied by the heart rate.
Measurement of cardiac output (CO) is used to quantify the performance of the left ventricle. It is commonly achieved using a pulmonary artery catheter (PAC) (also known ad Swann-Ganz catheter). A known amount of saline solution is injected in the proximal part of the catheter and the variation of blood temperature detected at the tip. Cardiac output is measured based on the duration and degree of temperature change. This method remains an accepted gold standard. TEE allows measurement of cardiac output using a number of different 2D and 3D imaging modalities. Although current guidelines identify the Method of the Disks(MOD) as the gold standard other technique could potentially be more precise. In this study, the investigators want to assess the accuracy of four different TEE methods to measure cardiac output compared with Thermodilution as a standard of care.
Read the detailed description
The measurement of the LV performance, as reflected by measuring cardiac output (CO), is an important component of hemodynamic assessment during cardiac (and non-cardiac) surgery. It has become standard of care in guiding fluid management and inotropic therapy in both the operating room (OR) and the intensive care unit (ICU) in most centres, and is considered by far the most understood and commonly communicated parameter of cardiac performance, in addition to being consistently shown as a predictor of patients' outcome.
Several methods have been used to measure CO. The most commonly used is via thermodilution (PAC), but its invasive nature and potential for serious complications led to the utilization of the non-invasive methods, such as those based on TEE.
Since the establishment of the role of TEE in the setting of hemodynamic monitoring during cardiac surgery, various ways of quantifying LV function have been utilized. The method recommended by current guidelines is a volumetric calculation via the method of disks (modified Simpson's method, MOD). Recent advances in ultrasound technology and software development allow the utilization three-dimensional (3D) volumetric assessment and speckle tracking for cardiac deformation.
- Conditions
- Cardiac Disease
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TEE vs PAC | we will compare the SV measurements obtained by PAC thermodilution technique to those obtained by different TEE methods in 60 patients undergoing coronary artery bypass grafting (CABG) and/or aortic valve (AV) or aortic surgery with cardiopulmonary bypass (CPB) in 2 different cardiac centres. The LV cardiac deformation, expressed as global longitudinal strain (GLS) will be calculated off-line from the acquired images. We will also determine the intra and inter-observer reproducibility of each TEE method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary Objective is to compare five different intraoperative echocardiographic measurements of cardiac output with the gold standard thermodilution in patients undergoing elective cardiac surgery.
Measured: Intraoperatively
Secondary outcomes (1)
The secondary objective is to test each TEE method against the standard of care method of the disks
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Aug 2017
- Primary completion5 May 2018
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Carroll, University Health Network, Toronto
- Investigators
- Massimiliano Meineri, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349970
- Sponsor's protocol ID
- 16-6341
- Status last verified
- May 2019
- First submitted
- 17 Nov 2017
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Measurement of Cardiac Output During Cardiac Surgery: Which TEE Method is Best?
- ClinicalTrials.gov ID
- NCT03349970
- Acronym / sponsor ID
- 16-6341
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 22 Nov 2017 (actual)
- 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.
Transesophageal echocardiography (TEE) has become a standard monitoring tool during cardiac surgery. It allows continuous accurate assessment of heart structures and function without interfering with the surgery and the anesthetics. The imaging of cardiac structures is used to direct optimal surgical intervention and assess surgical results. Cardiac output (CO) is the result of stroke volume (SV) multiplied by the heart rate.
Measurement of cardiac output (CO) is used to quantify the performance of the left ventricle. It is commonly achieved using a pulmonary artery catheter (PAC) (also known ad Swann-Ganz catheter). A known amount of saline solution is injected in the proximal part of the catheter and the variation of blood temperature detected at the tip. Cardiac output is measured based on the duration and degree of temperature change. This method remains an accepted gold standard. TEE allows measurement of cardiac output using a number of different 2D and 3D imaging modalities. Although current guidelines identify the Method of the Disks(MOD) as the gold standard other technique could potentially be more precise. In this study, the investigators want to assess the accuracy of four different TEE methods to measure cardiac output compared with Thermodilution as a standard of care.
Detailed description
The measurement of the LV performance, as reflected by measuring cardiac output (CO), is an important component of hemodynamic assessment during cardiac (and non-cardiac) surgery. It has become standard of care in guiding fluid management and inotropic therapy in both the operating room (OR) and the intensive care unit (ICU) in most centres, and is considered by far the most understood and commonly communicated parameter of cardiac performance, in addition to being consistently shown as a predictor of patients' outcome.
Several methods have been used to measure CO. The most commonly used is via thermodilution (PAC), but its invasive nature and potential for serious complications led to the utilization of the non-invasive methods, such as those based on TEE.
Since the establishment of the role of TEE in the setting of hemodynamic monitoring during cardiac surgery, various ways of quantifying LV function have been utilized. The method recommended by current guidelines is a volumetric calculation via the method of disks (modified Simpson's method, MOD). Recent advances in ultrasound technology and software development allow the utilization three-dimensional (3D) volumetric assessment and speckle tracking for cardiac deformation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEE vs PAC | – | –we will compare the SV measurements obtained by PAC thermodilution technique to those obtained by different TEE methods in 60 patients undergoing coronary artery bypass grafting (CABG) and/or aortic valve (AV) or aortic surgery with cardiopulmonary bypass (CPB) in 2 different cardiac centres. The LV cardiac deformation, expressed as global longitudinal strain (GLS) will be calculated off-line from the acquired images. We will also determine the intra and inter-observer reproducibility of each TEE method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac patients undergoing elective CABG, AV or aortic surgery (aortic root and ascending aortic arch surgery), with CPB
Key inclusion criteria (2 listed)
- age >18
- undergoing elective CABG, AV or aortic surgery (aortic root and ascending aortic arch surgery), with CPB.
Key exclusion criteria (4 listed)
- Emergency surgery
- Moderate or severe valve pathology
- Atrial fibrillation
- Patients with known contraindications to either the insertion of a PAC or the use of TEE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary Objective is to compare five different intraoperative echocardiographic measurements of cardiac output with the gold standard thermodilution in patients undergoing elective cardiac surgery.
Time frame: Intraoperatively
1 secondary outcome
The secondary objective is to test each TEE method against the standard of care method of the disks
Time frame: Intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No
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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.
Massimiliano Meineri, MD principal investigator
University Health Network, Toronto
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by University Health Network, Toronto at 2 sites in 2 countries.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
Results are not available in the source record.
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?
The primary Objective is to compare five different intraoperative echocardiographic measurements of cardiac output with the gold standard thermodilution in patients undergoing elective cardiac surgery. (time frame: Intraoperatively). 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 14 May 2019.