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

NCT04981548 | Unknown

• 1 other identifier: 21K081-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasonography

Keywords

optic nerve sheath diameter; intracranial pressure

Outcome Measures

Primary Outcomes (2)

• The normal range of ONSD in healthy Chinese adults.

  We will perform ONSD measurements with normal people by using ultrasound. We aim to establish the range for optic nerve sheath diameter (ONSD) in healthy Chinese adults. And the normal range of ONSD will be measured and reported.

  2021.8-2022.8

• determine the ONSD cut-off point for high intracranial pressure.

  We will perform ONSD measurements with patients who was suspected high intracranial pressure rand enquiring lumbar puncture. We will analyze the correlation between ONSD and intracranial pressure. And ONSD cut-off point for evaluating high intracranial pressure will be reported.

  2021.8-2022.8

Study Arms (2)

raised intracranial pressure

more than 200 mmH2O

Other: no intervention

the normal intracranial pressure group

more than 80 mmH2O and no more than 200 mmH2O

Other: no intervention

Interventions

no intervention OTHER

no intervention

raised intracranial pressure; the normal intracranial pressure group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected high intracranial pressure requiring lumbar puncture to measure spinal fluid pressure. The normal population is healthy volunteers with matching gender and age, requiring previous physical fitness, has no history of eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma.

You may qualify if:

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

You may not qualify if:

• eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma
• People with poor temporal window penetration.
• Patients who refuse to sign informed consent.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

the first hospital of Jilin university

Changchun, Jilin, 1300021, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29392301 BACKGROUND

Central Study Contacts

Sibo Wang, PhD

CONTACT

15844008297; wangsibo92@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: November 6, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: the study protocal will become available on December 2022 and for 2 years.

Locations

CN (1)