Resuscitative TEE Collaborative Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cardiac Arrest, Cardiac Arrest Circulatory, Cardiac Arrest, Out-Of-Hospital, Shock, Hemodynamic Instability

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Out-of-hospital Cardiac Arrest<br>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<br>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<br>Patients receiving TEE as part of the initial evaluation of undifferentiated shock or acute hemodynamic decompensation | |
| Hemodynamic Monitoring in a Critically Ill Patient<br>Critically ill patients receiving TEE as part of hemodynamic monitoring | |
| Procedural Guidance<br>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?
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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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transesophageal Echocardiography, Resuscitation, Cardiac Arrest, Point-of-care Ultrasound, Focused Cardiac Ultrasound