Validating TEE Measurements of Right Ventricular Function (TEE)

June 21, 2019 updated by: Shayne Michael Roberts, Milton S. Hershey Medical Center

Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function

Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and diagnosis in the perioperative setting for critically ill patients and patients undergoing cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography (TTE) data and have not validated by transesophageal means. The aim of this study is to validate TEE assessment of right ventricular function by comparing them to simultaneously measured TTE measurements.

Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the investigators will attempt to define a range of normal values of RV free wall strain as compared to the other measures of RV function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Traditionally, all echocardiographic measurements have been studied utilizing TTE. Therefore the normal values and ranges for pathology findings have been defined by transthoracic means alone. TEE offers different images planes when compared to TTE, which may make the measurements obtained differ from those obtained by TTE. In the operating room environment the vast majority of echocardiography is completed by transesophageal means for many reasons; largely access to the patient and the continuous use of TEE as a hemodynamic monitor. However, given the fact that most echocardiographic measurements have only been validated by TTE, there remains a question as to the validity or precision of TEE-derived measurements.

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing elective cardiac surgery, which as a standard of care, requires transesophageal echocardiography.

Description

Inclusion Criteria:

  • Adult patients undergoing elective cardiac surgery requiring TEE

Exclusion Criteria:

  • Patient who do not wish to consent
  • Patients with contraindications to TEE
  • Urgent or emergent cardiac surgery
  • Patients with preexisting open chest
  • Patients with intrathoracic hardware (VAD, thoracostomy tube, etc)
  • Non-English speaking subjects
  • Cognitively impaired adults
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right ventricular index of myocardial performance (RIMP)
Time Frame: Immediately following the induction of anesthesia and TEE probe placement
Right ventricular index of myocardial performance (RIMP) will be measured using both TTE and TEE.
Immediately following the induction of anesthesia and TEE probe placement
Tricuspid annular plane systolic excursion (TAPSE)
Time Frame: Immediately following the induction of anesthesia and TEE probe placement
Tricuspid annular plane systolic excursion (TAPSE) will be measured using both TTE and TEE.
Immediately following the induction of anesthesia and TEE probe placement
Right ventricular fractional area change (FAC)
Time Frame: Immediately following the induction of anesthesia and TEE probe placement
Right ventricular fractional area change (FAC) will be measured using both TTE and TEE.
Immediately following the induction of anesthesia and TEE probe placement
RV annular systolic velocity (S')
Time Frame: Immediately following the induction of anesthesia and TEE probe placement
RV annular systolic velocity (S') will be measured using both TTE and TEE.
Immediately following the induction of anesthesia and TEE probe placement
RV free wall longitudinal strain
Time Frame: Immediately following the induction of anesthesia and TEE probe placement
RV free wall longitudinal strain will be measured using both TTE and TEE.
Immediately following the induction of anesthesia and TEE probe placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of obtaining appropriate TEE measures of right ventricular function
Time Frame: Within 15 minutes following anesthesia induction
Ease of acquisition will be assessed by the echocardiographers
Within 15 minutes following anesthesia induction
Define values for normal right ventricular free wall strain
Time Frame: Through study completion, an estimate of 1 year
The data collected will be used to define normal values for right ventricular free wall strain
Through study completion, an estimate of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Shayne M Roberts, DO, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 18, 2017

Primary Completion (ACTUAL)

October 10, 2018

Study Completion (ACTUAL)

October 10, 2018

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (ACTUAL)

August 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00007541

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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