Observational Prospective Transesophageal Myocardial Ultrasound Survey

NCT02927041 | Withdrawn FDA Device

• 1 other identifier: HSC-MS-16-0376
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

hemodynamic transesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

• Mortality and Morbidity

  Comparing 30 day mortality and morbidity

  30 days

Secondary Outcomes (4)

• Organ dysfunction and failure

  30 days

• Blood product administration

  48 hours

• Length of ICU stay

  30 days

• Hospital stay

  30 days

Study Arms (2)

OR-Trauma

Patients presenting with hemodynamic instability with expected intubation greater than 24 hours. Hemodynamic monitoring with transesophageal echo and hemodynamic support/ interventions include volume resuscitation, vasopressors, and positive inotropes. The Anesthesiologist may or may not use the information provided by the transesophageal echocardiography.

Device: transesophageal echocardiography (hTEE)

OR-Cardiovascular

Requiring non-isolated cardiac surgery for repair of thoracic aortic aneurysm. Hemodynamic monitoring with transesophageal echo and hemodynamic support/ interventions include volume resuscitation, vasopressors, and positive inotropes. The Anesthesiologist may or may not use the information provided by the transesophageal echocardiography.

Device: transesophageal echocardiography (hTEE)

Interventions

transesophageal echocardiography (hTEE) DEVICE

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

Also known as: hTEE

OR-Cardiovascular; OR-Trauma

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients 18 to 85 years of age requiring hemodynamic monitoring during surgery for traumatic injury or non-isolated cardiac and vascular procedures.

You may qualify if:

• All study subjects 18 to 85 years old.
• OR-Trauma patients Presenting w/ hemodynamic instability. W/ expected intubation greater than 24 hours.
• CVICU patients (Cardiovascular Intensive Care Unit) Requiring non-isolated cardiac and vascular surgery

You may not qualify if:

• Current or previous esophageal injury

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Memorial Hermann Health System: collaborator

Related Publications (3)

• Vieillard-Baron A, Slama M, Mayo P, Charron C, Amiel JB, Esterez C, Leleu F, Repesse X, Vignon P. A pilot study on safety and clinical utility of a single-use 72-hour indwelling transesophageal echocardiography probe. Intensive Care Med. 2013 Apr;39(4):629-35. doi: 10.1007/s00134-012-2797-4. Epub 2013 Jan 4.

  PMID: 23287876 BACKGROUND

• Gouveia V, Marcelino P, Reuter DA. The role of transesophageal echocardiography in the intraoperative period. Curr Cardiol Rev. 2011 Aug;7(3):184-96. doi: 10.2174/157340311798220511.

  PMID: 22758616 BACKGROUND

• Treskatsch S, Balzer F, Knebel F, Habicher M, Braun JP, Kastrup M, Grubitzsch H, Wernecke KD, Spies C, Sander M. Feasibility and influence of hTEE monitoring on postoperative management in cardiac surgery patients. Int J Cardiovasc Imaging. 2015 Oct;31(7):1327-35. doi: 10.1007/s10554-015-0689-8. Epub 2015 Jun 6.

  PMID: 26047772 BACKGROUND

MeSH Terms

Interventions

Echocardiography, Transesophageal

Intervention Hierarchy (Ancestors)

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

Study Officials

• Robert C Wegner, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 6, 2016
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 3, 2025

Record last verified: 2025-09