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Clinical Trials/NCT03264183
NCT03264183
Completed
Not Applicable

Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function

Milton S. Hershey Medical Center1 site in 1 country126 target enrollmentSeptember 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Function, Right
Sponsor
Milton S. Hershey Medical Center
Enrollment
126
Locations
1
Primary Endpoint
Tricuspid annular plane systolic excursion (TAPSE)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2017
End Date
October 10, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shayne Michael Roberts

Assistant Professor

Milton S. Hershey Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

Secondary Outcomes

  • Ease of obtaining appropriate TEE measures of right ventricular function(Within 15 minutes following anesthesia induction)
  • Define values for normal right ventricular free wall strain(Through study completion, an estimate of 1 year)

Study Sites (1)

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