Resuscitative TEE Collaborative Registry

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT04972526
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Jan 2026
Primary completion
Dec 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.)
  • Arm: 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.)
  • Arm: Undifferentiated Shock or Acute Hemodynamic Decompensation
    Patients receiving TEE as part of the initial evaluation of undifferentiated shock or acute hemodynamic decompensation
  • Arm: Hemodynamic Monitoring in a Critically Ill Patient
    Critically ill patients receiving TEE as part of hemodynamic monitoring
  • Arm: 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.)

Primary Outcome Measure

The clinical impact and safety of TEE performed during the evaluation of critically ill patients in the emergency department and intensive care settings. [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Eileen McDonnell
[email protected]
215-746-5610
Felipe Teran, MD, MSCE (SUB_INVESTIGATOR)
Benjamin Abella, MD, MPhil (PRINCIPAL_INVESTIGATOR)

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