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NCT04972526 Clinical Trial

Resuscitative TEE Collaborative Registry

Cardiac Arrest Clinical Trial

— rTEECoRe  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04972526
Other study ID # 844522
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 15, 2024

Study information
Verified date January 2024
Source University of Pennsylvania
Contact Aarthi Kaviyarasu, BS
Phone 614-906-4711
Email aarthi.kaviyarasu@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
University of Pennsylvania Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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 The use of the TEE imaging modality in subsets of critically-ill patients in shock and cardiac arrest. 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
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