Clinical trial NCT04972526: Resuscitative TEE Collaborative Registry
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Cardiac Arrest Circulatory
Cardiac Arrest, Out-Of-Hospital
Shock
Hemodynamic Instability
Keywords: Transesophageal Echocardiography
Resuscitation
Cardiac Arrest
Point-of-care Ultrasound
Focused Cardiac Ultrasound
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2021-07-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The clinical impact and safety of TEE performed during the evaluation of critically ill patients in the emergency department and intensive care settings.
timeFrame: 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:
measure: The use of the TEE imaging modality in subsets of critically-ill patients in shock and cardiac arrest.
timeFrame: 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
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Weill Medical College of Cornell University
name: Felipe Teran, MD, MSCE
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Benjamin Abella, MD, MPhil
role: STUDY_DIRECTOR
References:
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.
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.
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.
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