NCT04510363

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress91%
Dec 2019Dec 2026

Study Start

First participant enrolled

December 17, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

7 years

First QC Date

August 2, 2020

Last Update Submit

May 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • optic nerve sheath diameter (ONSD)

    ONSD measured by ultrasonography during the post-arrest care

    7 days

  • carotid artery resistance

    carotid artery resistance measured by ultrasonography during the post-arrest care

    7 days

  • middle cerebral artery resistance

    middle cerebral artery resistance measured by ultrasonography during the post-arrest care

    7 days

Study Arms (2)

cardiac arrest survivors

cardiac arrest survivors

age- and sex-matched controls

age- and sex-matched controls

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-traumatic cardiac arrest adult patients achieving return of spontaneous circulation after resuscitation

You may qualify if:

  • Non-traumatic cardiac arrest adult patients achieving return of spontaneous circulation after resuscitation

You may not qualify if:

  • traumatic cardiac arrests
  • non-traumatic arrest patients without return of spontaneous circulation after resuscitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wan-Ching Lien, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan-Ching Lien, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 2, 2020

First Posted

August 12, 2020

Study Start

December 17, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations