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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01080495
First received: February 11, 2010
Last updated: March 3, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Ventricular Function, Left
Procedure: TEE (transesophageal echocardiography)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Radial Strain Versus Fractional Shortening and Fractional Area Change for Assessment of Left Ventricular Function in Transesophageal Echocardiography

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • left ventricular function [ Time Frame: 3min during TEE ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3min during TEE ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 33
Study Start Date: February 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TEE (transesophageal echcardiography)
all patients get TEE and all parameters (radial strain, fractional shortening and fractional area change) are evaluated
Procedure: TEE (transesophageal echocardiography)
a TEE is performed in all study objects and all parameters (radial strain, fractional shortening and fractional area change) are analysed
Other Name: radial strain

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080495

Contacts
Contact: Ulrike Weber, M. D. +43 40400 4109 ulrike.weber@meduniwien.ac.at
Contact: Heinz Tschernich, M. D. +43 404004109 heinz.tschernich@meduniwien.ac.at

Locations
Austria
University Hospital of Vienna Recruiting
Vienna, Austria, 1090
Contact: Ulrike Weber, M.D.    0043 1404004109    ulrike.weber@meduniwien.ac.at   
Principal Investigator: Ulrike Weber, M.D.         
Principal Investigator: Eva Base, M.D.         
Principal Investigator: Heinz Tschernich, M. D.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ulrike Weber, M.D. Department of Anaesthesiology, Intensive Care and Pain Control, University Hospital of Vienna
  More Information

No publications provided

Responsible Party: Department of Anaesthesiology, Intensive Care and Pain Control, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01080495     History of Changes
Other Study ID Numbers: 787/2009
Study First Received: February 11, 2010
Last Updated: March 3, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
left ventricular function
radial strain
fractional shortening
fractional area change

ClinicalTrials.gov processed this record on November 25, 2014