Neurologic DysfunctionNCT04510363
Optic Nerve Sheath Diameter, Carotid Duplex and Transcranial Duplex as a Prognostic Factor
An observational study of Neurologic Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neurologic Dysfunction
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Dec 2019to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-traumatic cardiac arrest adult patients achieving return of spontaneous circulation after resuscitation
Who may be able to join
- . Non-traumatic cardiac arrest adult patients achieving return of spontaneous circulation after resuscitation
Who cannot join
- traumatic cardiac arrests
- non-traumatic arrest patients without return of spontaneous circulation after resuscitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wan-Ching Lien, MD., PhD, +886-2-23123456 ext. 65637, wanchinglien@ntu.edu.tw
About this study
Official title: Optic Nerve Sheath Diameter, Carotid Duplex and Transcranial Duplex as a Prognostic Predicting Factor in Post-cardiac Arrest Patients
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.
Read the detailed 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.
- Conditions
- Neurologic Dysfunction
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cardiac arrest survivors | cardiac arrest survivors | |
| age- and sex-matched controls | age- and sex-matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter (ONSD)
ONSD measured by ultrasonography during the post-arrest care
Measured: 7 days
carotid artery resistance
carotid artery resistance measured by ultrasonography during the post-arrest care
Measured: 7 days
middle cerebral artery resistance
middle cerebral artery resistance measured by ultrasonography during the post-arrest care
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start17 Dec 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan-Ching Lien, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510363
- Sponsor's protocol ID
- 201911027RINC
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No