Ventricular Function, LeftPhase 4StrainNCT01080495
Evaluation of Radial Strain for Assessment of Left Ventricular Function in Transesophageal Echocardiography
A Phase 4 study testing TEE (transesophageal echocardiography) in people with Ventricular Function, Left, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Function, Left
- What is being tested?
- TEE (transesophageal echocardiography)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2010to Dec 2010
- Phase
- Phase 4
- 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
Who may be able to join
- Planned non-cardiac surgery with a minimum duration of 60 minutes, where intubation is indicated
- Age above 18 years
- Signed informed consent
Who cannot join
- No patient's consent
- Subjects not able to understand study procedures
- Contraindications to transesophageal echocardiography (oesophageal-, gastric disorders, hematologic disorders with increased bleeding incidence, ENT-surgery, surgery of the oesophagus or stomach)
- Medical history of any kind of heart disease, dyspnea or angina pectoris
- Hypertension (medically treated)
- Diabetes
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University Hospital of Vienna
Vienna, State of Vienna, 1090
Ulrike Weber, M.D., 0043 1404004109, ulrike.weber@meduniwien.ac.at
Ulrike Weber, M.D.
About this study
Official title: Evaluation of Radial Strain Versus Fractional Shortening and Fractional Area Change for Assessment of Left Ventricular Function in Transesophageal Echocardiography
Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography.
Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC).
Radial strain is a new parameter to asses left ventricular function. The investigators want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.
Read the detailed description
Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography.
Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC). These parameters can be assessed in the transgastric mid papillary short axis view (TG SAX) to quantify left ventricular systolic function. Limitations of these methods are the experience of the investigator - the more experienced the investigator the more reliable and reproducible the data are, load dependency of these methods and the geometrical assumption of a one-dimensional measurement for assessment of a three-dimensional contracting left ventricle. Therefore, LV-function will either be over- or underestimated by influence of segmental wall motion abnormalities or by missing them.
Radial strain allows reliable and reproducible evaluation of left ventricular function and also allows assessment of myocardial deformation from representative segments of each wall of the left ventricle. Myocardial strain is described as the relative deformation of a myocardial fiber, normalized to its original length:L1-L0/L0(%). Strain is positive (radial thickening) if L1>L0 and negative (longitudinal shortening and circumferential thinning) if L1<L0. Radial strain is sensitive to changes in contractility and less influenced by loading conditions which occur frequently during anaesthesia in a wide spectrum of non-cardiac surgery as a result of blood loss or loss of hemodynamic autoregulation due to anesthetic drugs.
Therefore we want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.
Study hypothesis
The aim of the study is to compare fractional shortening (FS) and fractional area change (FAC) with radial strain from TG mid SAX using TEE in the anaesthetized patient undergoing non-cardiac surgery. Furthermore we want to investigate the influence of changes in loading conditions on these parameters in the anaesthetized non-cardiac patient undergoing non-cardiac surgery. Therefore patients are examined in zero position, trendelenburg- and anti-trendelenburg-position.
Hypothesis:
- Radial strain correlates with FAC and FS in assessment of left ventricular function in patients undergoing non-cardiac surgery. FAC is of primary interest because it has several advantages: it is very easy to calculate, it´s considered a surrogate of ejection fraction, and several studies have shown that it is an excellent measure of left ventricular function even in patients with heterogeneity of regional function.
- The parameters radial strain, fractional shortening and fractional area change correlate during are changes in loading conditions (zero-position, trendelenburg- and anti-trendelenburg-maneuver).
Study design: prospective cohort study Inclusion criteria
- Planned non-cardiac surgery with a minimum duration of 60 minutes, where intubation is indicated
- Age above 18 years
- Signed informed consent Exclusion criteria
- No patient's consent
- Subjects not able to understand study procedures
- Contraindications to transesophageal echocardiography (oesophageal-, gastric disorders, hematologic disorders with increased bleeding incidence, ENT-surgery, surgery of the oesophagus or stomach)
- Medical history of any kind of heart disease, dyspnea or angina pectoris
- Hypertension (medically treated)
- Diabetes
- Atrial fibrillation Study protocol One day prior to surgery the patients are screened and invited to participate in the study by the principle investigator. If they consent the principle investigator does a physical examination and takes their medical history.
On the day of surgery patients receive premedication as usual. Arriving at the operating room the patients are monitored with ECG, pulse oximetry and blood pressure (either invasive with insertion of an arterial catheter, when indicated, or non-invasive blood pressure). A peripheral venous line is needed for induction of anaesthesia. Induction and maintenance of anaesthesia is performed using standard protocols. After induction of anaesthesia and insertion of all needed catheters (central venous catheter, bladder catheter, arterial catheter, and eventually pulmonary artery catheter) the transoesophageal probe, covered with a special condom, will be inserted.
The examination will be done by the principle investigator (Dr. Ulrike Weber) under supervision of an expierenced investigator.
Intraoperative TEE-Examinations (T1, T2, T3)
At T1, T2, T3 TEE-study examinations are performed in zero position, Trendelenburg position, and anti-Trendelenburg position. Positioning will follow a random order according to a blinded randomization list.
Trendelenburg-position shall be defined for the study with 10cm head-down from horizontal position, anti-trendelenburg position with 10cm head-up (from horizontal position). After positioning examination will start after a 3 min delay for reaching a steady-state in loading conditions.
T1 - after induction of anesthesia
After insertion of the probe a transesophageal echo examination (TEE) is performed - including a complete routine clinical examination (T1):
T2 - Intraoperative TEE, 3min after positioning
Positioning (zero position, Trendelenburg, anti-trendelenburg) will be performed according to randomization. 3min after positioning, under stable hemodynamics, recordings of HR, blood pressure, FS, FAC, Radial strain
T3 - Intraoperative TEE, 3min after positioning
Positioning (zero position, Trendelenburg, anti-trendelenburg) will be performed according to randomization. 3min after positioning, under stable hemodynamics, recordings of HR, blood pressure, FS, FAC, Radial strain
The following measurements are taken for the study (3 times during sinus rhythm):
- FS in the transgastric short axis mid papillary view
- FAC in the transgastric short axis mid papillary view
- Radial strain in the transgastric short axis mid papillary view
Recordings of the 2D-mode images of the TG SAX shall be taken in triplicate with 3 heart cycles per stored clip. The images will be stored digitally in the EchoPAC-raw data format.
Analysis of data will be performed offline in a dedicated work station (EchoPAC, GE Vingmed, Horten, Norway). Three different investigators will analyse all data two times at two different time points.
Expected study population: 33 patients
- Conditions
- Ventricular Function, Left
- Being tested
- TEE (transesophageal echocardiography)
- Keywords
- left ventricular function, radial strain, fractional shortening, fractional area change
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEE (transesophageal echocardiography)Procedure or surgery
Also called radial strain
a TEE is performed in all study objects and all parameters (radial strain, fractional shortening and fractional area change) are analysed
| Study group | Role | What they receive |
|---|---|---|
| TEE (transesophageal echcardiography) | Other | all patients get TEE and all parameters (radial strain, fractional shortening and fractional area change) are evaluated Receives: Procedure: TEE (transesophageal echocardiography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular function
for left ventricular function transgastric short axis view is recorded 3 times for 3 heart cycles in 3 different positions (zero-position, trendelenburg- and antitrendelenburg-position)
Measured: 3min during TEE
Secondary outcomes (1)
left ventricular function during changes in loading conditions
for left ventricular function transgastric short axis view is recorded 3 times for 3 heart cycles in 3 different positions (zero-position, trendelenburg- and antitrendelenburg-position)
Measured: 3min during TEE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Function, LeftStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Ulrike Weber, M.D., Principal investigator, Department of Anaesthesiology, Intensive Care and Pain Control, University Hospital of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080495
- Sponsor's protocol ID
- 787/2009
- Acronym
- Strain
- Status last verified
- Feb 2010
- First submitted
- 11 Feb 2010
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radial Strain Versus Fractional Shortening and Fractional Area Change for Assessment of Left Ventricular Function in Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT01080495
- Acronym / sponsor ID
- Strain / 787/2009
- Conditions
- Ventricular Function, Left
- Keywords
- left ventricular function, radial strain, fractional shortening, fractional area change
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 4 Mar 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.
Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography.
Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC).
Radial strain is a new parameter to asses left ventricular function. The investigators want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.
Detailed description
Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography.
Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC). These parameters can be assessed in the transgastric mid papillary short axis view (TG SAX) to quantify left ventricular systolic function. Limitations of these methods are the experience of the investigator - the more experienced the investigator the more reliable and reproducible the data are, load dependency of these methods and the geometrical assumption of a one-dimensional measurement for assessment of a three-dimensional contracting left ventricle. Therefore, LV-function will either be over- or underestimated by influence of segmental wall motion abnormalities or by missing them.
Radial strain allows reliable and reproducible evaluation of left ventricular function and also allows assessment of myocardial deformation from representative segments of each wall of the left ventricle. Myocardial strain is described as the relative deformation of a myocardial fiber, normalized to its original length:L1-L0/L0(%). Strain is positive (radial thickening) if L1>L0 and negative (longitudinal shortening and circumferential thinning) if L1<L0. Radial strain is sensitive to changes in contractility and less influenced by loading conditions which occur frequently during anaesthesia in a wide spectrum of non-cardiac surgery as a result of blood loss or loss of hemodynamic autoregulation due to anesthetic drugs.
Therefore we want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.
Study hypothesis
The aim of the study is to compare fractional shortening (FS) and fractional area change (FAC) with radial strain from TG mid SAX using TEE in the anaesthetized patient undergoing non-cardiac surgery. Furthermore we want to investigate the influence of changes in loading conditions on these parameters in the anaesthetized non-cardiac patient undergoing non-cardiac surgery. Therefore patients are examined in zero position, trendelenburg- and anti-trendelenburg-position.
Hypothesis:
- Radial strain correlates with FAC and FS in assessment of left ventricular function in patients undergoing non-cardiac surgery. FAC is of primary interest because it has several advantages: it is very easy to calculate, it´s considered a surrogate of ejection fraction, and several studies have shown that it is an excellent measure of left ventricular function even in patients with heterogeneity of regional function.
- The parameters radial strain, fractional shortening and fractional area change correlate during are changes in loading conditions (zero-position, trendelenburg- and anti-trendelenburg-maneuver).
Study design: prospective cohort study Inclusion criteria
- Planned non-cardiac surgery with a minimum duration of 60 minutes, where intubation is indicated
- Age above 18 years
- Signed informed consent Exclusion criteria
- No patient's consent
- Subjects not able to understand study procedures
- Contraindications to transesophageal echocardiography (oesophageal-, gastric disorders, hematologic disorders with increased bleeding incidence, ENT-surgery, surgery of the oesophagus or stomach)
- Medical history of any kind of heart disease, dyspnea or angina pectoris
- Hypertension (medically treated)
- Diabetes
- Atrial fibrillation Study protocol One day prior to surgery the patients are screened and invited to participate in the study by the principle investigator. If they consent the principle investigator does a physical examination and takes their medical history.
On the day of surgery patients receive premedication as usual. Arriving at the operating room the patients are monitored with ECG, pulse oximetry and blood pressure (either invasive with insertion of an arterial catheter, when indicated, or non-invasive blood pressure). A peripheral venous line is needed for induction of anaesthesia. Induction and maintenance of anaesthesia is performed using standard protocols. After induction of anaesthesia and insertion of all needed catheters (central venous catheter, bladder catheter, arterial catheter, and eventually pulmonary artery catheter) the transoesophageal probe, covered with a special condom, will be inserted.
The examination will be done by the principle investigator (Dr. Ulrike Weber) under supervision of an expierenced investigator.
Intraoperative TEE-Examinations (T1, T2, T3)
At T1, T2, T3 TEE-study examinations are performed in zero position, Trendelenburg position, and anti-Trendelenburg position. Positioning will follow a random order according to a blinded randomization list.
Trendelenburg-position shall be defined for the study with 10cm head-down from horizontal position, anti-trendelenburg position with 10cm head-up (from horizontal position). After positioning examination will start after a 3 min delay for reaching a steady-state in loading conditions.
T1 - after induction of anesthesia
After insertion of the probe a transesophageal echo examination (TEE) is performed - including a complete routine clinical examination (T1):
T2 - Intraoperative TEE, 3min after positioning
Positioning (zero position, Trendelenburg, anti-trendelenburg) will be performed according to randomization. 3min after positioning, under stable hemodynamics, recordings of HR, blood pressure, FS, FAC, Radial strain
T3 - Intraoperative TEE, 3min after positioning
Positioning (zero position, Trendelenburg, anti-trendelenburg) will be performed according to randomization. 3min after positioning, under stable hemodynamics, recordings of HR, blood pressure, FS, FAC, Radial strain
The following measurements are taken for the study (3 times during sinus rhythm):
- FS in the transgastric short axis mid papillary view
- FAC in the transgastric short axis mid papillary view
- Radial strain in the transgastric short axis mid papillary view
Recordings of the 2D-mode images of the TG SAX shall be taken in triplicate with 3 heart cycles per stored clip. The images will be stored digitally in the EchoPAC-raw data format.
Analysis of data will be performed offline in a dedicated work station (EchoPAC, GE Vingmed, Horten, Norway). Three different investigators will analyse all data two times at two different time points.
Expected study population: 33 patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEE (transesophageal echcardiography) | Other | Procedure: TEE (transesophageal echocardiography)all patients get TEE and all parameters (radial strain, fractional shortening and fractional area change) are evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned non-cardiac surgery with a minimum duration of 60 minutes, where intubation is indicated
- Age above 18 years
- Signed informed consent
Key exclusion criteria (7 listed)
- No patient's consent
- Subjects not able to understand study procedures
- Contraindications to transesophageal echocardiography (oesophageal-, gastric disorders, hematologic disorders with increased bleeding incidence, ENT-surgery, surgery of the oesophagus or stomach)
- Medical history of any kind of heart disease, dyspnea or angina pectoris
- Hypertension (medically treated)
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 |
|---|---|---|
| TEE (transesophageal echocardiography)Also: radial straina TEE is performed in all study objects and all parameters (radial strain, fractional shortening and fractional area change) are analysed | Procedure or surgery | TEE (transesophageal echcardiography) |
Primary outcome
left ventricular function
Time frame: 3min during TEE
for left ventricular function transgastric short axis view is recorded 3 times for 3 heart cycles in 3 different positions (zero-position, trendelenburg- and antitrendelenburg-position)
1 secondary outcome
left ventricular function during changes in loading conditions
Time frame: 3min during TEE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2010.
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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.
Ulrike Weber, M.D. principal investigator
Department of Anaesthesiology, Intensive Care and Pain Control, University Hospital of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TEE (transesophageal echocardiography) in people with Ventricular Function, Left, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 7 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 4 Mar 2010. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ulrike Weber, M. D. (+43 40400 4109, ulrike.weber@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular function (time frame: 3min during TEE). 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 4 Mar 2010.