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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04510363
Other study ID # 201911027RINC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 17, 2019
Est. completion date December 16, 2023

Study information

Verified date December 2023
Source National Taiwan University Hospital
Contact Wan-Ching Lien, PhD
Phone +886-223123456
Email wanchinglien@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Optic nerve sheath diameter (ONSD) had been proved to be associated with increased intracranial pressure and can be used as one of the prognostic factors in cardiac arrest patients. It is simple, quick and can be measured repeatedly. Carotid duplex and transcranial duplex(TCD) provide rapid, noninvasive, real-time measures of cerebrovascular function. It can be used to assess the vascular territory by measuring blood flow, and to evaluate factors include brain perfusion, plaque morphology, and patency of intracranial collaterals. Hence, it could act as a crucial role in neuroprognosis in post-arrest patients. In this study, the investigator aimed to analyze the ONSD diameters, ONSD/external transverse diameter (ETD) ratio, carotid duplex and transcaranial duplex parameters in different stages of post-cardiac arrest care, demographic characteristics and resuscitation information with the neurological outcome of post-cardiac arrest patients. The ONSD diameter, and ONSD/ETD ratio were compared with age-, and sex-matched normal volunteers.


Description:

Prediction of the neurological outcome in resuscitated post-cardiac arrest patients is important to tailor appropriate management plans. Brain imaging, electrophysiological evaluations, biomarkers all take part in neuroprognosis in cardiac arrest patients, however, these modalities are more expensive or not suitable to repeat in a short time. Optic nerve sheath diameter (ONSD) had been proved to be associated with increased intracranial pressure2 and can be used as one of the prognostic factors in cardiac arrest patients. It is simple, quick and can be measured repeatedly. Carotid duplex and transcranial duplex(TCD) provide rapid, noninvasive, real-time measures of cerebrovascular function. It can be used to assess the vascular territory by measuring blood flow, and to evaluate factors include brain perfusion, plaque morphology, and patency of intracranial collaterals. Hence, it could act as a crucial role in neuroprognosis in post-arrest patients. In this study, the investigator aimed to analyze the ONSD diameters, ONSD/ETD ratio, carotid duplex and transcaranial duplex parameters in different stages of post-cardiac arrest care, demographic characteristics and resuscitation information with the neurological outcome of post-cardiac arrest patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 16, 2023
Est. primary completion date December 16, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: . Non-traumatic cardiac arrest adult patients achieving return of spontaneous circulation after resuscitation Exclusion Criteria: - traumatic cardiac arrests - non-traumatic arrest patients without return of spontaneous circulation after resuscitation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary optic nerve sheath diameter (ONSD) ONSD measured by ultrasonography during the post-arrest care 7 days
Primary carotid artery resistance carotid artery resistance measured by ultrasonography during the post-arrest care 7 days
Primary middle cerebral artery resistance middle cerebral artery resistance measured by ultrasonography during the post-arrest care 7 days
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