Application of Transesophageal Echocardiography in Pre-hospital Cardiac Arrest Patients

NCT06672315 | Recruiting DMC FDA Device

• 1 other identifier: 113027-F
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The Use of Point-of-Care Ultrasound (POCUS), Transthoracic Echocardiography (TTE), and Transesophageal Echocardiography (TEE) in Cardiac Arrest and Acute Coronary Syndrome Patients Studies have shown that POCUS can rapidly change the management in nearly 80% of cases in emergency settings, particularly in environments such as war zones and disaster relief. TTE is highly sensitive in diagnosing acute coronary syndromes and can effectively rule out myocardial infarction. In cardiac arrest patients, TTE assists in determining cardiac activity and identifying reversible causes, such as pericardial tamponade and pneumothorax. However, TTE can be affected by suboptimal image quality due to factors like chest compression in out-of-hospital cardiac arrest (OHCA) patients. In Taiwan's emergency medical system, EMT-Ps (paramedics) undergo approximately one year of training, which enables them to provide emergency care, including ultrasound examinations, before hospital arrival. Research on pre-hospital cardiac arrest has shown that most ultrasound applications can be completed within 3 minutes and do not significantly increase on-scene time. TEE, though advantageous for its high-quality imaging and ability to reduce interruptions during chest compressions, faces challenges in pre-hospital emergency applications due to specialized training and equipment requirements. However, a study in Vienna, Austria, demonstrated that TEE could be performed and yield high-quality images in most pre-hospital cases, with an average examination time of 5.1 minutes. Several hospitals in Taiwan have begun training personnel in TEE, emphasizing the importance of establishing TEE image registries for large-scale, effective research analysis. However, these efforts also face challenges related to resources and collaboration. The research team has over three years of experience using TEE in the emergency department to examine OHCA patients, and a three-year study will be conducted to validate the efficacy of pre-hospital TEE in cardiac arrest patients.

Conditions

Out-of-hospital Cardiac Arrest (OHCA)

Keywords

Left Ventricular Outflow Tract; Transesophageal Echocardiography; TEE; LVOT; OHCA

Outcome Measures

Primary Outcomes (1)

• Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment

  Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment. The proportion of successfully ensuring LV compression during prehospital CPR.

  30 days after cardiac arrest or upon the patient's death, whichever came first

Secondary Outcomes (5)

• Sustained return of spontaneous circulation (sustained ROSC) lasting approximately 20 minutes

  Patient sustained ROSC for 20 minutes after

• Time from the start of resuscitation to the first return of spontaneous circulation (ROSC)

  1 minute after patient first ROSC

• Any ROSC rate

  1 minute after patient ROSC

• Favorable neurologic outcome with discharge to home (Cerebral Performance Category 1 or 2)

  Up to 6 months after discharge date

• End-tidal carbon dioxide (EtCO2)

  One hour after arriving at the hospital

Study Arms (2)

Performing TEE

EXPERIMENTAL

In this group of patients, transesophageal echocardiography (TEE) will be performed to confirm optimal chest compression positioning while utilizing a mechanical chest compression device.

Diagnostic Test: transesophageal echocardiography

not performing TEE

NO INTERVENTION

In this group of patients, transesophageal echocardiography (TEE) will not be performed, and the mechanical chest compression device will be positioned at the intersection of the nipple line and the sternum.

Interventions

transesophageal echocardiography DIAGNOSTIC_TEST

Confirmation of chest compression positioning via transesophageal echocardiography (TEE)

Performing TEE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients with out-of-hospital cardiac arrest (OHCA)
• Non-traumatic cause of cardiac arrest

You may not qualify if:

• Presence of obvious signs of death, such as decapitation, rigor mortis, livor mortis, or decomposition.
• Family explicitly expresses a Do Not Attempt Resuscitation (DNR) order, or the patient has a documented refusal of resuscitation.
• Any condition that contraindicates the use of transesophageal echocardiography (TEE), such as esophageal tumors, preventing probe insertion.
• Patients eligible for ECPR (Extracorporeal Cardiopulmonary Resuscitation) treatment.
• Spontaneous circulation has already been stabilized before performing TEE.

Sponsors & Collaborators

• Jen-Tang Sun: lead

Study Sites (1)

Far Eastern Memorinal Hospital and New Taipei City fire department

New Taipei City, 220, Taiwan

RECRUITING

Related Publications (18)

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• Atkinson P, Bowra J, Milne J, Lewis D, Lambert M, Jarman B, Noble VE, Lamprecht H, Harris T, Connolly J; and members of the International Federation of Emergency Medicine Sonography in Hypotension and Cardiac Arrest working group: Romolo Gaspari, MD, PhD; Ross Kessler, MD; Christopher Raio, MD; Paul Sierzenski, MD; Beatrice Hoffmann, MD; Chau Pham, MD; Michael Woo, MD; Paul Olszynski, MD; Ryan Henneberry, MD; Oron Frenkel, MD; Jordan Chenkin, MD; Greg Hall, MD; Louise Rang, MD; Maxime Valois, MD; Chuck Wurster, MD; Mark Tutschka, MD; Rob Arntfield, MD; Jason Fischer, MD; Mark Tessaro, MD; J. Scott Bomann, DO; Adrian Goudie, MB; Gaby Blecher, MB; Andree Salter, MB; Michael Rose, MB; Adam Bystrzycki, MB; Shailesh Dass, MB; Owen Doran, MB; Ruth Large, MB; Hugo Poncia, MB; Alistair Murray, MB; Jan Sadewasser, MD; Raoul Breitkreutz, MD; Hong Chuen Toh, MB; Arif Alper Cevik, MD; Ang Shiang Hu, MB; Larry Melniker, MD, MS. International Federation for Emergency Medicine Consensus Statement: Sonography in hypotension and cardiac arrest (SHoC): An international consensus on the use of point of care ultrasound for undifferentiated hypotension and during cardiac arrest. CJEM. 2017 Nov;19(6):459-470. doi: 10.1017/cem.2016.394. Epub 2016 Dec 21.

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  PMID: 29866583 BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Jen-Tang Sun

CONTACT

+886 2 77281843; femhresearch@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Emergency Surgery

Model Details: Patients aged 18 years or older who have experienced out-of-hospital cardiac arrest (OHCA) due to non-traumatic causes

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: November 4, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)