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Hemodynamic InstabilityOPTEMUSNCT02927041

Observational Prospective Transesophageal Myocardial Ultrasound Survey

An observational study of Hemodynamic Instability, run by The University of Texas Health Science Center, Houston.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hemodynamic Instability
What is being tested?
transesophageal echocardiography (hTEE)
Type of treatment
Medical device
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2018to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • • 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

Who cannot join

  • Current or previous esophageal injury

About this study

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.

Read more

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.

Read the detailed description

The device can evaluate trans-valvular flow as well as valvular regurgitation with the use of the color flow function. In many situations hTEE enables imaging not feasible by transthoracic echocardiography due to wounds, dressings, lines or edema.

The hTEE does not provide the visual acuity and detail of formal TEE, but it has the advantage of requiring a significantly smaller probe (hence the decreased risk of possible injury) with the ability of providing rapid, repeatable and sequential assessment by caregivers intraoperatively or at the bedside.

Data will be reviewed for outcome measures comparing efficiency, accuracy and clinical decision making capability of the FDA approved hTEE cardiac monitoring system vs. the standard of care Swan-Ganz/ echocardiographic information for publication. The ultimate goal will be to demonstrate whether or not after implementation of probes in surgical trauma and CVICU patients, there is a difference in:

  1. Mortality and Morbidity
  2. Organ dysfunction and failure
  3. Blood product administration
  4. Length of ICU stay
  5. Hospital stay
  6. Study Design and Statistical Procedures This is a two phase, single center, non-blinded, non-randomized, observational and retrospective study to be carried out at Memorial Hermann Hospital. The data from the hTEE study group will be compared to the control group (in-house OR-Trauma and CV surgery databases) and will be analyzed on a patient to patient basis for its impact on clinical decision-making.

Based upon our literature review, we hypothesize that hTEE will help guide point-of-care management upwards of 75 percent of cases. A decrease in iatrogenic complications from inappropriate blood product administration, volume resuscitation and or drug intervention based off of antiquated protocols and inaccurate technology is expected. Its use may benefit the hospital financially by decreasing the incidence of organ failure and mortality and allowing for the fulfillment of discharge criteria earlier from the hospital.

  1. Study Procedures
  2. Initiation A. Development of protocol and datasheet. (1 month) B. Training of anesthesia attendings, fellows, residents and technicians. (1 month) C. Formal presentation at Grand rounds. (1 month)
  3. OR- Trauma/ CVICU:
  4. Training of the primary proceduralists. Board runners - 892 office. (1 month) B. Recording of real-time hemodynamic transesophageal echocardiographic movies of 60 patients. (3 months) C. Image analysis for clinical decision making with research assistants. (3 months)
  5. Database retrospective review of above stated endpoints. (3 months) After admission to the OR and fulfillment of inclusion criteria, the hTEE probe will be placed by a trained attending or fellow as per standard care. A standardized exam will be performed that includes a: (1) superior vena cava view, (2) trans-esophageal four-chamber view and a (3) trans-gastric short axis view. As per current standard care, the information will be documented in the medical record and discussed with the PI, key study personnel and the patient's physician. For the purpose of the study, we will document carefully what impact the hTEE assessment has on the management plan on the first 60 patients who meet criteria and compare results to the standard of care use of CVP/ Echocardiography combination in terms of clinical decision making. Subsequent hTEE assessments will be made sequentially as clinically indicated, and the information obtained will be analyzed in the same way. All images will be stored for clinical interpretation on the machine itself, which is accessible to authorized personnel only. All patient data that is collected for the study will be coded; No subject identifiers will be recorded on study forms. See the privacy and confidentiality section for details.
  6. Study Drugs or Devices: N/A
  7. Study Instruments: N/A
  8. Study Subjects:

Inclusion criteria:

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

Exclusion criteria:

Current or previous esophageal injury

Being tested
transesophageal echocardiography (hTEE)
Keywords
hemodynamic transesophageal echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transesophageal echocardiography (hTEE)Device

    Also called hTEE

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

Study groups in NCT02927041
Study groupRoleWhat they receive
OR-TraumaPatients 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.
Receives: Device: transesophageal echocardiography (hTEE)
OR-CardiovascularRequiring 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.
Receives: Device: transesophageal echocardiography (hTEE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality and Morbidity

    Comparing 30 day mortality and morbidity

    Measured: 30 days

Secondary outcomes (4)
  1. Organ dysfunction and failure

    Comparing 30 day organ dysfunction and failure

    Measured: 30 days

  2. Blood product administration

    Comparing Blood product administration during initial 48 hours

    Measured: 48 hours

  3. Length of ICU stay

    Comparing Length of ICU stay

    Measured: 30 days

  4. Hospital stay

    Comparing Hospital stay

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study startDec 2018 (estimated)
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Why it stopped: Funding and supplies ran out

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02927041
Sponsor's protocol ID
HSC-MS-16-0376
Acronym
OPTEMUS
Status last verified
Sep 2025
First submitted
4 Oct 2016
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23287876
  • 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.

    PubMed 22758616
  • 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.

    PubMed 26047772

Questions about this trial

What is this clinical trial studying?

An observational study of Hemodynamic Instability, run by The University of Texas Health Science Center, Houston.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality and Morbidity (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02927041, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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