NCT04972526

Brief Summary

The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE. The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings. The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Dec 2020Dec 2027

Study Start

First participant enrolled

December 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

7 years

First QC Date

June 15, 2021

Last Update Submit

January 12, 2026

Conditions

Keywords

Transesophageal EchocardiographyResuscitationCardiac ArrestPoint-of-care UltrasoundFocused Cardiac Ultrasound

Outcome Measures

Primary Outcomes (1)

  • The clinical impact and safety of TEE performed during the evaluation of critically ill patients in the emergency department and intensive care settings.

    Determination of ROSC and survival to hospital discharge

    From the time of admission to the hospital until the date of discharge from the hospital or date of death from any cause, whichever occurs first, assessed up to 12 weeks

Secondary Outcomes (1)

  • The use of the TEE imaging modality in subsets of critically-ill patients in shock and cardiac arrest.

    From the time of admission to the hospital until the date of discharge from the hospital or date of death from any cause, whichever occurs first, assessed up to 12 weeks

Study Arms (5)

Out-of-hospital Cardiac Arrest

Patients receiving TEE as part of their clinical evaluation during cardiac arrest that occurred outside the hospital (e.g. in/at a home or residence, in a public area, during transport to the emergency department, etc.)

In-hospital Cardiac Arrest

Patients receiving TEE as part of the clinical evaluation during cardiac arrest that occurred within a hospital (e.g in the emergency department, an Intensive Care Unit, a hospital ward, the operating room, etc.)

Undifferentiated Shock or Acute Hemodynamic Decompensation

Patients receiving TEE as part of the initial evaluation of undifferentiated shock or acute hemodynamic decompensation

Hemodynamic Monitoring in a Critically Ill Patient

Critically ill patients receiving TEE as part of hemodynamic monitoring

Procedural Guidance

Patients receiving TEE as a means to assist providers performing procedures (e.g. intravenous pacemaker placement, veno-arterial or veno-venous extracorporeal membrane oxygenation \[ECMO\], impella heart pump placement, intra-aortic balloon pump placement, etc.)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult critically-ill patients who as part of their routine clinical care receive focused TEE in the emergency department of intensive care setting.

You may qualify if:

  • Adult critically-ill patients who as part of their routine clinical care receive focused TEE in the emergency department of intensive care setting.

You may not qualify if:

  • Children (age under 18 years)
  • Vulnerable populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (19)

  • Teran F, Prats MI, Nelson BP, Kessler R, Blaivas M, Peberdy MA, Shillcutt SK, Arntfield RT, Bahner D. Focused Transesophageal Echocardiography During Cardiac Arrest Resuscitation: JACC Review Topic of the Week. J Am Coll Cardiol. 2020 Aug 11;76(6):745-754. doi: 10.1016/j.jacc.2020.05.074.

    PMID: 32762909BACKGROUND
  • Teran F, Burns KM, Narasimhan M, Goffi A, Mohabir P, Horowitz JM, Yuriditsky E, Nagdev A, Panebianco N, Chin EJ, Gottlieb M, Koenig S, Arntfield R. Critical Care Transesophageal Echocardiography in Patients during the COVID-19 Pandemic. J Am Soc Echocardiogr. 2020 Aug;33(8):1040-1047. doi: 10.1016/j.echo.2020.05.022. Epub 2020 May 23.

    PMID: 32600742BACKGROUND
  • Teran F, Dean AJ, Centeno C, Panebianco NL, Zeidan AJ, Chan W, Abella BS. Evaluation of out-of-hospital cardiac arrest using transesophageal echocardiography in the emergency department. Resuscitation. 2019 Apr;137:140-147. doi: 10.1016/j.resuscitation.2019.02.013. Epub 2019 Feb 16.

    PMID: 30779977BACKGROUND
  • Arntfield R, Lau V, Landry Y, Priestap F, Ball I. Impact of Critical Care Transesophageal Echocardiography in Medical-Surgical ICU Patients: Characteristics and Results From 274 Consecutive Examinations. J Intensive Care Med. 2020 Sep;35(9):896-902. doi: 10.1177/0885066618797271. Epub 2018 Sep 6.

    PMID: 30189783BACKGROUND
  • Lerner RP, Haaland A, Lin J. Temporary transvenous pacer placement under transesophageal echocardiogram guidance in the Emergency Department. Am J Emerg Med. 2020 May;38(5):1044.e3-1044.e4. doi: 10.1016/j.ajem.2019.12.027. Epub 2019 Dec 16.

    PMID: 31870671BACKGROUND
  • Catena E, Ottolina D, Fossali T, Rech R, Borghi B, Perotti A, Ballone E, Bergomi P, Corona A, Castelli A, Colombo R. Association between left ventricular outflow tract opening and successful resuscitation after cardiac arrest. Resuscitation. 2019 May;138:8-14. doi: 10.1016/j.resuscitation.2019.02.027. Epub 2019 Feb 27.

    PMID: 30825552BACKGROUND
  • Osman A, Fong CP, Wahab SFA, Panebianco N, Teran F. Transesophageal Echocardiography at the Golden Hour: Identification of Blunt Traumatic Aortic Injuries in the Emergency Department. J Emerg Med. 2020 Sep;59(3):418-423. doi: 10.1016/j.jemermed.2020.05.003. Epub 2020 Jun 23.

    PMID: 32591302BACKGROUND
  • Hwang SO, Zhao PG, Choi HJ, Park KH, Cha KC, Park SM, Kim SC, Kim H, Lee KH. Compression of the left ventricular outflow tract during cardiopulmonary resuscitation. Acad Emerg Med. 2009 Oct;16(10):928-33. doi: 10.1111/j.1553-2712.2009.00497.x. Epub 2009 Sep 3.

    PMID: 19732038BACKGROUND
  • Fair J 3rd, Mallin MP, Adler A, Ockerse P, Steenblik J, Tonna J, Youngquist ST. Transesophageal Echocardiography During Cardiopulmonary Resuscitation Is Associated With Shorter Compression Pauses Compared With Transthoracic Echocardiography. Ann Emerg Med. 2019 Jun;73(6):610-616. doi: 10.1016/j.annemergmed.2019.01.018. Epub 2019 Feb 14.

    PMID: 30773413BACKGROUND
  • Parker BK, Salerno A, Euerle BD. The Use of Transesophageal Echocardiography During Cardiac Arrest Resuscitation: A Literature Review. J Ultrasound Med. 2019 May;38(5):1141-1151. doi: 10.1002/jum.14794. Epub 2018 Oct 2.

    PMID: 30280396BACKGROUND
  • Teran F. Resuscitative Cardiopulmonary Ultrasound and Transesophageal Echocardiography in the Emergency Department. Emerg Med Clin North Am. 2019 Aug;37(3):409-430. doi: 10.1016/j.emc.2019.03.003. Epub 2019 May 21.

    PMID: 31262412BACKGROUND
  • Jaidka A, Hobbs H, Koenig S, Millington SJ, Arntfield RT. Better With Ultrasound: Transesophageal Echocardiography. Chest. 2019 Jan;155(1):194-201. doi: 10.1016/j.chest.2018.09.023. Epub 2018 Oct 9.

    PMID: 30312590BACKGROUND
  • Vieillard-Baron A, Chergui K, Rabiller A, Peyrouset O, Page B, Beauchet A, Jardin F. Superior vena caval collapsibility as a gauge of volume status in ventilated septic patients. Intensive Care Med. 2004 Sep;30(9):1734-9. doi: 10.1007/s00134-004-2361-y. Epub 2004 Jun 26.

    PMID: 15375649BACKGROUND
  • Blaivas M. Transesophageal echocardiography during cardiopulmonary arrest in the emergency department. Resuscitation. 2008 Aug;78(2):135-40. doi: 10.1016/j.resuscitation.2008.02.021. Epub 2008 May 16.

    PMID: 18486300BACKGROUND
  • Arntfield R, Pace J, McLeod S, Granton J, Hegazy A, Lingard L. Focused transesophageal echocardiography for emergency physicians-description and results from simulation training of a structured four-view examination. Crit Ultrasound J. 2015 Dec;7(1):27. doi: 10.1186/s13089-015-0027-3. Epub 2015 Jun 12.

    PMID: 26123608BACKGROUND
  • Arntfield R, Pace J, Hewak M, Thompson D. Focused Transesophageal Echocardiography by Emergency Physicians is Feasible and Clinically Influential: Observational Results from a Novel Ultrasound Program. J Emerg Med. 2016 Feb;50(2):286-94. doi: 10.1016/j.jemermed.2015.09.018. Epub 2015 Oct 24.

    PMID: 26508495BACKGROUND
  • Fair J, Tonna J, Ockerse P, Galovic B, Youngquist S, McKellar SH, Mallin M. Emergency physician-performed transesophageal echocardiography for extracorporeal life support vascular cannula placement. Am J Emerg Med. 2016 Aug;34(8):1637-9. doi: 10.1016/j.ajem.2016.06.038. Epub 2016 Jun 7.

    PMID: 27318746BACKGROUND
  • Byars DV, Tozer J, Joyce JM, Vitto MJ, Taylor L, Kayagil T, Jones M, Bishop M, Knapp B, Evans D. Emergency Physician-performed Transesophageal Echocardiography in Simulated Cardiac Arrest. West J Emerg Med. 2017 Aug;18(5):830-834. doi: 10.5811/westjem.2017.5.33543. Epub 2017 Jul 19.

    PMID: 28874934BACKGROUND
  • Fair J, Mallin M, Mallemat H, Zimmerman J, Arntfield R, Kessler R, Bailitz J, Blaivas M. Transesophageal Echocardiography: Guidelines for Point-of-Care Applications in Cardiac Arrest Resuscitation. Ann Emerg Med. 2018 Feb;71(2):201-207. doi: 10.1016/j.annemergmed.2017.09.003. Epub 2017 Nov 6.

    PMID: 29107407BACKGROUND

Related Links

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac ArrestShock

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Felipe Teran, MD, MSCE

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
  • Clark G Owyang, MD

    Weill Medical College of Cornell University

    STUDY CHAIR

Central Study Contacts

Felipe Teran, MD, MSCE

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Resuscitative TEE Collaborative Registry

Study Record Dates

First Submitted

June 15, 2021

First Posted

July 22, 2021

Study Start

December 1, 2020

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2027

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations