Back to resultsEXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest (EXECT_CPR)
Primary Purpose
Out-Of-Hospital Cardiac Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
transesophageal echocardiography examination during cardiopulmonary resuscitation
Sponsored by
About this trial
This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest focused on measuring Out-Of-Hospital Cardiac Arrest, Chest compression site, transesophageal echocardiography, end-tidal CO2
Eligibility Criteria
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.
Sites / Locations
- Far Eastern Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
Perform standard advanced life support. No examination of transesophageal echocardiography during cardiopulmonary resuscitation.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rate of any return of spontaneous circulation
successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR)
Rate of survival to admission
successful restoration and maintenance of a patient's heartbeat and blood circulation for 48 hours
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
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
end-tidal carbon dioxide (EtCO2)
measuring end-tidal carbon dioxide during resuscitation
Full Information
NCT ID
NCT05907460
First Posted
June 8, 2023
Last Updated
June 20, 2023
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05907460
Brief Title
EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest
Acronym
EXECT_CPR
Official Title
EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest
Keywords
Out-Of-Hospital Cardiac Arrest, Chest compression site, transesophageal echocardiography, end-tidal CO2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
This is an open label study
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Perform standard advanced life support. No examination of transesophageal echocardiography during cardiopulmonary resuscitation.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
transesophageal echocardiography examination during cardiopulmonary resuscitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of sustained return of spontaneous circulation (ROSC)
Description
successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR) for at least 20 minutes
Time Frame
20 minutes after ROSC
Secondary Outcome Measure Information:
Title
Rate of any return of spontaneous circulation
Description
successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR)
Time Frame
1 minutes after ROSC
Title
Rate of survival to admission
Description
successful restoration and maintenance of a patient's heartbeat and blood circulation for 48 hours
Time Frame
48 hours after ROSC
Title
Rate of survival to discharge
Description
successful restoration and maintenance of a patient's heartbeat and blood circulation and able to complete treatment course till discharge
Time Frame
6 months after ROSC
Title
Rate of discharge with favorable neurological outcomes
Description
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
Time Frame
6 months after ROSC
Title
end-tidal carbon dioxide (EtCO2)
Description
measuring end-tidal carbon dioxide during resuscitation
Time Frame
During resuscitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Tang Sun, MD, Msc
Phone
0919388100
Email
tangtang05231980@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chiao-Yin Cheng, Mac
Phone
0937421091
Email
chiaoyin810406@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Tang Sun, MD, Msc
Organizational Affiliation
Attending physician of emergency medicine department
Official's Role
Study Chair
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Banqiao
State/Province
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Tang Sun
Phone
886-2-89667000
Email
tangtang05231980@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest
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