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Completed

NCT Number: NCT03264183

Validating TEE 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.

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Key information

Conditions

Ventricular Function, Right Echocardiography, Transesophageal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transesophageal Echocardiography

Diagnostic Test

TEE measures of right ventricular function

Other names: TEE

Transthoracic echocardiography

Diagnostic Test

TTE measures of right ventricular function

Other names: TTE

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function

Acronym: TEE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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