Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT04972526

Conditions

Cardiac Arrest

Cardiac Arrest Circulatory

Cardiac Arrest, Out-Of-Hospital

Shock

Hemodynamic Instability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cardiac Arrest

Cardiac Arrest Circulatory

Cardiac Arrest, Out-Of-Hospital

Shock

Hemodynamic Instability

Study ID

NCT04972526

Start date

Dec 1, 2020

Status verified date

Aug, 2026

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.)

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 and Locations

Central contacts

James R Quinlan

7175792198jrq6@cornell.edu

Felipe Teran, MD, MSCE

9172573841

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Michelle Santangelo, MS

7175792198Michelle_Santangelo@rush.edu

Principal Investigator:

Felipe Teran, MD, MSCE

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Transesophageal Echocardiography
  • Resuscitation
  • Cardiac Arrest
  • Point-of-care Ultrasound
  • Focused Cardiac Ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-10.