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Validating TEE Measurements of Right Ventricular Function

Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03264183
Acronym
TEE
Enrollment
126
Registered
2017-08-29
Start date
2017-09-18
Completion date
2018-10-10
Last updated
2019-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography, Transesophageal, Ventricular Function, Right

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.

Interventions

DIAGNOSTIC_TESTTransesophageal Echocardiography

TEE measures of right ventricular function

DIAGNOSTIC_TESTTransthoracic Echocardiography

TTE measures of right ventricular function

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tricuspid annular plane systolic excursion (TAPSE)Immediately following the induction of anesthesia and TEE probe placementTricuspid annular plane systolic excursion (TAPSE) will be measured using both TTE and TEE.
RV annular systolic velocity (S')Immediately following the induction of anesthesia and TEE probe placementRV annular systolic velocity (S') will be measured using both TTE and TEE.
RV free wall longitudinal strainImmediately following the induction of anesthesia and TEE probe placementRV free wall longitudinal strain will be measured using both TTE and TEE.
Right ventricular index of myocardial performance (RIMP)Immediately following the induction of anesthesia and TEE probe placementRight ventricular index of myocardial performance (RIMP) will be measured using both TTE and TEE.
Right ventricular fractional area change (FAC)Immediately following the induction of anesthesia and TEE probe placementRight ventricular fractional area change (FAC) will be measured using both TTE and TEE.

Secondary

MeasureTime frameDescription
Define values for normal right ventricular free wall strainThrough study completion, an estimate of 1 yearThe data collected will be used to define normal values for right ventricular free wall strain
Ease of obtaining appropriate TEE measures of right ventricular functionWithin 15 minutes following anesthesia inductionEase of acquisition will be assessed by the echocardiographers

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026