NCT05932784

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

July 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

June 27, 2023

Last Update Submit

June 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

  • 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

Study Arms (1)

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

Interventions

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.

Also known as: TEE
OHCA patients receiving TEE

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Early ROSC before obtaining TEE image;
  • Insert the REBOA before ROSC;
  • Initiate ECMO flow before ROSC;
  • Cannot identify compression site on TEE;
  • Poor quality of TEE image;
  • Missing TEE image.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

October 1, 2020

Primary Completion

January 31, 2023

Study Completion

May 1, 2023

Last Updated

July 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations