Clinical trial NCT03264183: Validating TEE Measurements of Right Ventricular Function
Official title: Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Function, Right
Echocardiography, Transesophageal
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing elective cardiac surgery, which as a standard of care, requires transesophageal echocardiography.

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.

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

Primary outcomes:
measure: Right ventricular index of myocardial performance (RIMP)
timeFrame: Immediately following the induction of anesthesia and TEE probe placement
measure: Tricuspid annular plane systolic excursion (TAPSE)
timeFrame: Immediately following the induction of anesthesia and TEE probe placement
measure: Right ventricular fractional area change (FAC)
timeFrame: Immediately following the induction of anesthesia and TEE probe placement
measure: RV annular systolic velocity (S')
timeFrame: Immediately following the induction of anesthesia and TEE probe placement
measure: RV free wall longitudinal strain
timeFrame: Immediately following the induction of anesthesia and TEE probe placement
Secondary outcomes:
measure: Ease of obtaining appropriate TEE measures of right ventricular function
timeFrame: Within 15 minutes following anesthesia induction
measure: Define values for normal right ventricular free wall strain
timeFrame: Through study completion, an estimate of 1 year
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Shayne M Roberts, DO
role: PRINCIPAL_INVESTIGATOR
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