Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: ORIENT Study

NCT ID: NCT04981548

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-06

Study Completion Date

2023-11-30

Brief Summary

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This study aims to adopt a multi-center large sample size study to define (1) the normal range of Chinese ONSD; (2) ONSD diagnosis for patients with high intracranial pressure; (3) to analyze the correlation between ONSD and intracranial pressure.

Detailed Description

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The ONSD, transcranial Doppler parameters and baseline data of the normal intracranial pressure group and the enhanced intracranial pressure group (more than 200 mmH2O) .

Conditions

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Ultrasonography

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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raised intracranial pressure

more than 200 mmH2O

no intervention

Intervention Type OTHER

no intervention

the normal intracranial pressure group

more than 80 mmH2O and no more than 200 mmH2O

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. People requiring lumbar puncture testing due to brain trauma, intracranial infection, intracranial vascular disease, intracranial tumors, peripheral neuropathy for the raised intracranial pressure group.
2. Healthy people for the normal intracranial pressure group.

Exclusion Criteria

1. eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma
2. People with poor temporal window penetration.
3. Patients who refuse to sign informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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LIJUAN WANG

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the first hospital of Jilin university

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Sibo Wang, PhD

Role: CONTACT

15844008297

Facility Contacts

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Sibo Wang, MD

Role: primary

15844008297

References

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Wang LJ, Chen LM, Chen Y, Bao LY, Zheng NN, Wang YZ, Xing YQ. Ultrasonography Assessments of Optic Nerve Sheath Diameter as a Noninvasive and Dynamic Method of Detecting Changes in Intracranial Pressure. JAMA Ophthalmol. 2018 Mar 1;136(3):250-256. doi: 10.1001/jamaophthalmol.2017.6560.

Reference Type BACKGROUND
PMID: 29392301 (View on PubMed)

Other Identifiers

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21K081-001

Identifier Type: -

Identifier Source: org_study_id

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