EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest

NCT05907460 | Completed DMC

• 1 other identifier: 109070-F
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this single center, randomized clinical control trial is to determine that changing chest compression site during cardiopulmonary resuscitation according to the examination of the TEE could increase the level of end-tidal CO2, which represents the quality of cardiopulmonary resuscitation, or not in adult patients with non-traumatic out-of-hospital cardiac arrest while comparing to those who don't receive examination of transesophageal echocardiography during cardiopulmonary resuscitation.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Out-Of-Hospital Cardiac Arrest; Chest compression site; transesophageal echocardiography; end-tidal CO2

Outcome Measures

Primary Outcomes (1)

• Rate of sustained return of spontaneous circulation (ROSC)

  successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR) for at least 20 minutes

  20 minutes after ROSC

Secondary Outcomes (5)

• Rate of any return of spontaneous circulation

  1 minutes after ROSC

• Rate of survival to ICU admission

  48 hours after ROSC

• Rate of survival to discharge

  6 months after ROSC

• Rate of discharge with favorable neurological outcomes

  6 months after ROSC

• end-tidal carbon dioxide (EtCO2)

  During resuscitation

Study Arms (2)

Control group

NO INTERVENTION

Perform standard advanced life support. No examination of transesophageal echocardiography during cardiopulmonary resuscitation.

Intervention group

EXPERIMENTAL

Perform examination of transesophageal echocardiography during cardiopulmonary resuscitation and adjust the chest compression site to avoid left ventricular outflow tract according to the result of transesophageal echocardiography

Device: transesophageal echocardiography examination during cardiopulmonary resuscitation

Interventions

transesophageal echocardiography examination during cardiopulmonary resuscitation DEVICE

Perform transesophageal echocardiography in patients with out-of-hospital cardiac arrest during cardiopulmonary resuscitation and adjust the chest compression site to compress the left ventricle and avoid left ventricular outflow tract.

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years-old
• Out-of-hospital cardiac arrest
• Non-trauma

You may not qualify if:

• Obvious signs of death appears, such as separation of head and body, rigor mortis, livor mortis, cankered corpse......etc.
• Family members clearly express the willing of do not attempt resuscitation or patients who have registered advance care planning not to attempt resuscitation.
• Patients not suitable for transesophageal ultrasound, such as patients with esophageal tumor, those whose probe cannot be placed......etc.
• Received Extracorporeal CPR.
• Achieving sustained ROSC before ED arrival

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jun-Tang Sun, MD, Msc

  Attending physician of emergency medicine department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: June 29, 2023
• Primary Completion: November 19, 2023
• Study Completion: November 19, 2023
• Last Updated: October 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)