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

NCT01080495 | Unknown Phase 4

• 1 other identifier: 787/2009
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Function, Left

Keywords

left ventricular function; radial strain; fractional shortening; fractional area change

Outcome Measures

Primary Outcomes (1)

• 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)

  3min during TEE

Secondary Outcomes (1)

• left ventricular function during changes in loading conditions

  3min during TEE

Study Arms (1)

TEE (transesophageal echcardiography)

OTHER

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

Procedure: TEE (transesophageal echocardiography)

Interventions

TEE (transesophageal echocardiography) PROCEDURE

a TEE is performed in all study objects and all parameters (radial strain, fractional shortening and fractional area change) are analysed

Also known as: radial strain

TEE (transesophageal echcardiography)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned non-cardiac surgery with a minimum duration of 60 minutes, where intubation is indicated
• Age above 18 years
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

University Hospital of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ulrike Weber, M.D.

  Department of Anaesthesiology, Intensive Care and Pain Control, University Hospital of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrike Weber, M. D.

CONTACT

+43 40400 4109; ulrike.weber@meduniwien.ac.at

Heinz Tschernich, M. D.

CONTACT

+43 404004109; heinz.tschernich@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: March 4, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 4, 2010

Record last verified: 2010-02

Locations

AU (1)