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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05932784
Other study ID # 109070-F-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date May 1, 2023

Study information

Verified date February 2023
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date May 1, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital Banqiao New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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