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Evaluation of Radial Strain for Assessment of Left Ventricular Function in Transesophageal Echocardiography (Strain)

Primary Purpose

Ventricular Function, Left

Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
TEE (transesophageal echocardiography)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ventricular Function, Left focused on measuring left ventricular function, radial strain, fractional shortening, fractional area change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TEE (transesophageal echcardiography)

Arm Description

all patients get TEE and all parameters (radial strain, fractional shortening and fractional area change) are evaluated

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
February 11, 2010
Last Updated
March 3, 2010
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01080495
Brief Title
Evaluation of Radial Strain for Assessment of Left Ventricular Function in Transesophageal Echocardiography
Acronym
Strain
Official Title
Evaluation of Radial Strain Versus Fractional Shortening and Fractional Area Change for Assessment of Left Ventricular Function in Transesophageal Echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Function, Left
Keywords
left ventricular function, radial strain, fractional shortening, fractional area change

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEE (transesophageal echcardiography)
Arm Type
Other
Arm Description
all patients get TEE and all parameters (radial strain, fractional shortening and fractional area change) are evaluated
Intervention Type
Procedure
Intervention Name(s)
TEE (transesophageal echocardiography)
Other Intervention Name(s)
radial strain
Intervention Description
a TEE is performed in all study objects and all parameters (radial strain, fractional shortening and fractional area change) are analysed
Primary Outcome Measure Information:
Title
left ventricular function
Description
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)
Time Frame
3min during TEE
Secondary Outcome Measure Information:
Title
left ventricular function during changes in loading conditions
Description
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)
Time Frame
3min during TEE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrike Weber, M. D.
Phone
+43 40400 4109
Email
ulrike.weber@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Heinz Tschernich, M. D.
Phone
+43 404004109
Email
heinz.tschernich@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Weber, M.D.
Organizational Affiliation
Department of Anaesthesiology, Intensive Care and Pain Control, University Hospital of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrike Weber, M.D.
Phone
0043 1404004109
Email
ulrike.weber@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Ulrike Weber, M.D.
First Name & Middle Initial & Last Name & Degree
Eva Base, M.D.
First Name & Middle Initial & Last Name & Degree
Heinz Tschernich, M. D.

12. IPD Sharing Statement

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Evaluation of Radial Strain for Assessment of Left Ventricular Function in Transesophageal Echocardiography

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