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

Sponsor

Far Eastern Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05907460

Collaborator

(none)

132

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Out-Of-Hospital Cardiac Arrest	Device: transesophageal echocardiography examination during cardiopulmonary resuscitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

This is an open label study

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 19, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

May 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of sustained return of spontaneous circulation (ROSC) [20 minutes after ROSC]
successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR) for at least 20 minutes

Secondary Outcome Measures

Rate of any return of spontaneous circulation [1 minutes after ROSC]
successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR)
Rate of survival to admission [48 hours after ROSC]
successful restoration and maintenance of a patient's heartbeat and blood circulation for 48 hours
Rate of survival to discharge [6 months after ROSC]
successful restoration and maintenance of a patient's heartbeat and blood circulation and able to complete treatment course till discharge
Rate of discharge with favorable neurological outcomes [6 months after ROSC]
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
end-tidal carbon dioxide (EtCO2) [During resuscitation]
measuring end-tidal carbon dioxide during resuscitation

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.
While the researcher is not available.