The Impact of Aortic Valve Compression During Cardio-pulmonary Resuscitation on Patients With Out-of-hospital Cardiac Arrest (AVC in OHCA)

The Impact of Aortic Valve Compression During Cardio-pulmonary Resuscitation on Patients With Out-of-hospital Cardiac Arrest: A Single-center Observational Study Using Transesophageal Echocardiography

Purpose:

This study aims to find out if the current way of performing chest compressions during resuscitation for patients who have suffered a cardiac arrest outside of the hospital is affecting their chances of recovery. Recent research suggests that more than half of these patients receive chest compressions near their aortic valve, which might block blood flow and make their condition worse. We will use a special imaging technique called transesophageal echocardiography (TEE) during resuscitation to see if compressions near the aortic valve impact patient outcomes.

Methods:

We will conduct a study with patients who have suffered a cardiac arrest outside of the hospital and are receiving TEE during resuscitation in the emergency department. Some patients will not be included in the study, such as those who recover quickly before the TEE is done, those who need other treatments before they recover, those with an unclear compression site, or those with poor or missing TEE images. We will divide the patients into two groups: those with compressions near their aortic valve and those without. We will collect information on the patients, the TEE recordings, the resuscitation process, and important time points. We will mainly look at whether the patients recover and maintain a steady heartbeat. We will also examine other factors like their carbon dioxide levels, whether they recover at all, if they survive to be admitted to the hospital, if they survive to be discharged, and if they have good brain function when they leave the hospital. We plan to have 37 patients in each group for accurate results.

Study Overview

• Status: Completed
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Device: transesophageal echocardiography

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City
    • Banqiao, New Taipei City, Taiwan, 220
      • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients aged 20 or older who arrived at the ED with non-traumatic OHCA and underwent TEE during resuscitation were enrolled, except for those meeting the following exclusion criteria: 1) Early ROSC before obtaining TEE image; 2) Insertion of REBOA before ROSC; 3) Initiation of ECMO flow before ROSC; 4) Unidentifiable compression site on TEE; 5) Poor quality TEE image; 6) Missing TEE image

Description

Inclusion Criteria:

• patients aged 20 or older who arrived at the ED with non-traumatic OHCA and underwent TEE during resuscitation

Exclusion Criteria:

1. Early ROSC before obtaining TEE image;
2. Insert the REBOA before ROSC;
3. Initiate ECMO flow before ROSC;
4. Cannot identify compression site on TEE;
5. Poor quality of TEE image;
6. Missing TEE image.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OHCA patients receiving TEE; Out-of-hospital cardiac arrest (OHCA) patients undergo transesophageal echocardiography (TEE) during resuscitation to determine if their aortic valve is being compressed.	Device: transesophageal echocardiography; Utilizing transesophageal echocardiography (TEE) during resuscitation allows medical professionals to determine if a patient's aortic valve is being compressed while receiving chest compressions, providing valuable insight to optimize the resuscitation process.; Other Names: TEE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time Frame
Any return of spontaneous circulation (ROSC)	1 minutes after ROSC
survival to admission	48 hours after ROSC
survival to discharge	6 months after ROSC
discharge with favorable neurological outcomes	6 months after ROSC
end-tidal carbon dioxide (EtCO2)	During resuscitation

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 109070-F-2

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