- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04972526
Resuscitative TEE Collaborative Registry (rTEECoRe)
Evaluation of the Clinical Impact and Safety of Focused Transesophageal Echocardiography During Resuscitation of Critically Ill Patients in the Emergency Department and Intensive Care Settings
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.
Study Overview
Status
Detailed Description
Vision
The Resuscitative TEE Collaborative Registry aims to accelerate the development of outcome-oriented research and knowledge translation on the use of TEE in emergency and critical care settings.
Mission
The registry aims to catalyze clinical research involving the use of TEE in critically-ill patients through the following strategic initiatives:
- Facilitate collaboration between different clinical teams and organizations across the entire spectrum of users of TEE in acute care setting, including emergency departments and intensive care units.
- Standardize data collection and reporting that enables multi-institutional data sharing.
- Provide an efficient research infrastructure that facilitates data capture, management and analysis, enabling teams around the world to conduct research studies in this field.
- Make shared data open and accessible to clinicians and researchers.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: James R Quinlan
- Phone Number: 7175792198
- Email: jrq6@cornell.edu
Study Contact Backup
- Name: Felipe Teran, MD, MSCE
- Phone Number: 9172573841
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- Rush University Medical Center
-
Contact:
- Michelle Santangelo, MS
- Phone Number: 7175792198
- Email: Michelle_Santangelo@rush.edu
-
Principal Investigator:
- Felipe Teran, MD, MSCE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult critically-ill patients who as part of their routine clinical care receive focused TEE in the emergency department of intensive care setting.
Exclusion Criteria:
- Children (age under 18 years)
- Vulnerable populations
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The clinical impact and safety of TEE performed during the evaluation of critically ill patients in the emergency department and intensive care settings.
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The use of the TEE imaging modality in subsets of critically-ill patients in shock and cardiac arrest.
Time Frame: 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
|
Description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Felipe Teran, MD, MSCE, Weill Medical College of Cornell University
- Study Chair: Clark G Owyang, MD, Weill Medical College of Cornell University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 844522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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