Resuscitative TEE Collaborative Registry

Recruiting

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

• Registration Number: NCT04972526
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

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Exclusion Criteria

• Children (age under 18 years)
• Vulnerable populations

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States