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

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.

Study Overview

• Status: Recruiting
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Device: transesophageal echocardiography examination during cardiopulmonary resuscitation

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun-Tang Sun, MD, Msc; Phone Number: 0919388100; Email: tangtang05231980@gmail.com
• Study Contact Backup: Name: Chiao-Yin Cheng, Mac; Phone Number: 0937421091; Email: chiaoyin810406@gmail.com

Study Locations

• Taiwan
  • New Taipei City
    • Banqiao, New Taipei City, Taiwan, 220
      • Recruiting
      • Far Eastern Memorial Hospital
      • Contact: Jun-Tang Sun; Phone Number: 886-2-89667000; Email: tangtang05231980@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 20 years-old
2. Out-of-hospital cardiac arrest
3. Non-trauma

Exclusion Criteria:

1. Obvious signs of death appears, such as separation of head and body, rigor mortis, livor mortis, cankered corpse......etc.
2. Family members clearly express the willing of do not attempt resuscitation or patients who have registered advance care planning not to attempt resuscitation.
3. Patients not suitable for transesophageal ultrasound, such as patients with esophageal tumor, those whose probe cannot be placed......etc.
4. While the researcher is not available.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Perform standard advanced life support. No examination of transesophageal echocardiography during cardiopulmonary resuscitation.
Experimental: Intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
end-tidal carbon dioxide (EtCO2)	measuring end-tidal carbon dioxide during resuscitation	During resuscitation
Rate of any return of spontaneous circulation	successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR)	1 minutes after ROSC
Rate of survival to admission	successful restoration and maintenance of a patient's heartbeat and blood circulation for 48 hours	48 hours after ROSC
Rate of survival to discharge	successful restoration and maintenance of a patient's heartbeat and blood circulation and able to complete treatment course till discharge	6 months after ROSC
Rate of discharge with favorable neurological outcomes	using cerebral performance category score to measure neurologic outcomes of the patient at the time while patient's discharge. CPC1 and 2 are consider as favorable neurological outcomes, CPC3 and 4 are consider as unfavorable neurological outcomes	6 months after ROSC

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Study Chair: Jun-Tang Sun, MD, Msc, Attending physician of emergency medicine department

Study record dates

Study Major Dates

• Study Start (Estimated): June 19, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: transesophageal echocardiography; Out-Of-Hospital Cardiac Arrest; end-tidal CO2; Chest compression site
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 109070-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No