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Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04600570
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
The investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. We plan to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.

Condition or disease Intervention/treatment
Normal Diameter of Optic Nerve Other: ultrasound

Detailed Description:

Ultrasound measurement of optic nerve sheath diameter (ONSD) had been considered as a non-invasive way to distinguish the presence of elevated intracranial pressure (ICP). Besides detecting elevated ICP in various neurological diseases, ONSD can also be applied to cardiac arrest survivors as one of the prognostic factors. It is a simple, quick, repeatable technique without the need of contrast medians. In order to make precise interpretations, the database of the normal distribution of ONSD and its associated factors in healthy volunteers is necessary. The majority of previous reports are from Western countries, and limited reports of ONSD in the Asian population have high variability.

Therefore, collecting local data of ONSD in Taiwan is important. In this study, the investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. The investigators planed to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers and Its Associating Factors
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : October 15, 2021
Estimated Study Completion Date : October 15, 2021
Groups and Cohorts
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Intervention Details:
  • Other: ultrasound
    ultrasound measurement for optic nerve outer diameter

Outcome Measures
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Primary Outcome Measures :
  1. optic nerve outer diameter [ Time Frame: 60 days ]
    optic nerve outer diameter


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
normal volunteers
Criteria

Inclusion Criteria:

adult volunteer aged more than 20 years

Exclusion Criteria:

aged less than 20 years

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600570


Contacts
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Contact: Wan-Ching Lien +886-23123456 ext 65637 wanchinglien@ntu.edu.tw
Contact: Dean-An Ling +886-23123456 ext 65637 speckle0714@gmail.com

Locations
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Taiwan
Department of Emergency Medicine, National Taiwan University Hospital Recruiting
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wan-Ching Lien NTUH
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04600570    
Other Study ID Numbers: 202008032RINC
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No