Validating TEE Measurements of Right Ventricular Function

NCT03264183 | Completed

• 1 other identifier: STUDY00007541
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Function, Right; Echocardiography, Transesophageal

Outcome Measures

Primary Outcomes (5)

• Right ventricular index of myocardial performance (RIMP)

  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)

  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)

  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')

  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

  RV free wall longitudinal strain will be measured using both TTE and TEE.

  Immediately following the induction of anesthesia and TEE probe placement

Secondary Outcomes (2)

• 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

Interventions

Transesophageal Echocardiography DIAGNOSTIC_TEST

TEE measures of right ventricular function

Also known as: TEE

Transthoracic Echocardiography DIAGNOSTIC_TEST

TTE measures of right ventricular function

Also known as: TTE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult patients undergoing elective cardiac surgery requiring TEE

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (28)

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MeSH Terms

Interventions

Echocardiography, Transesophageal; Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Shayne M Roberts, DO

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 29, 2017
• Study Start: September 18, 2017
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)