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Observational Prospective Transesophageal Myocardial Ultrasound Survey

NCT02927041 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-10-03

No results posted yet for this study

Summary

The gold standard in hemodynamic evaluation has been the combined use of echocardiography and right heart catheterization. Fall backs to echocardiography are its time consumption and requirement for specialist interpretation while the Swan-Ganz® catheter shows a poor correlation of central venous pressure to volume status and provides indirect and difficult to interpret measurements in patients with unique pathophysiological states.

Next generation continuous hemodynamic transesophageal echocardiography (hTEE®) is being increasingly utilized to assist with complex resuscitations and to monitor the hemodynamic profiles of critically ill patients. hTEE is proving to be an essential diagnostic, therapeutic and monitoring tool for the rapid evaluation of the hemodynamic state in the critically ill patient and or hemodynamically compromised patient.

The purpose of this observational study is to evaluate the role of hTEE in clinical decision-making in 30 patients recruited from OR-Trauma and in 30 patients from the Cardiovascular-OR. Hemodynamic trans-esophageal echocardiography (hTEE) incorporates an FDA-approved miniaturized, disposable probe for continuous use in patients for up to 72 hours. This device has been used for postoperative assessment in the ICU for several years with successful placement of probes and without any adverse incidents.

The probe allows for the rapid, intermittent or continuous evaluation of bi-ventricular function, volume status and valve function at bedside or intraoperatively. It also allows for the evaluation of pericardial effusions and or the exclusion of pericardial tamponade.

Conditions

  • Hemodynamic Instability

Interventions

DEVICE

transesophageal echocardiography (hTEE)

Hemodynamic interventions include volume resuscitation, vasopressors and positive inotropes. Anesthesiologist may or may not use the information provided by the transesophageal echocardiography.

Sponsors & Collaborators

  • Memorial Hermann Health System

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Robert C Wegner, MD · The University of Texas Health Science Center, Houston

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02927041 on ClinicalTrials.gov