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Resuscitative TEE Collaborative Registry

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04972526
Collaborator
(none)
1,000
Enrollment
1
Location
36.4
Anticipated Duration (Months)
27.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Jun 15, 2023
    Anticipated Study Completion Date :
    Dec 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.)

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Study Chair: Felipe Teran, MD, MSCE, University of Pennsylvania

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Felipe Teran, MD, MSCE, Chair, Resuscitative TEE Collaborative Registry, University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT04972526
    Other Study ID Numbers:
    • 844522
    First Posted:
    Jul 22, 2021
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Felipe Teran, MD, MSCE, Chair, Resuscitative TEE Collaborative Registry, University of Pennsylvania
    Transesophageal Echocardiography
    Resuscitation
    Cardiac Arrest
    Point-of-care Ultrasound
    Focused Cardiac Ultrasound
    Additional relevant MeSH terms:
    Heart Arrest
    Out-of-Hospital Cardiac Arrest

    Study Results

    No Results Posted as of Jul 22, 2021