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

Ultrasonography Clinical Trial

Official title:

Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: a Chinese Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981548
• Other study ID #: 21K081-001
• Status: Recruiting
• Start date: November 6, 2021
• Est. completion date: November 2023

Study information

• Verified date: July 2023
• Source: The First Hospital of Jilin University
• Contact: Sibo Wang, PhD
• Phone: 15844008297
• Email: wangsibo92[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intracranial Hypertension
• Ultrasonography

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	the first hospital of Jilin university	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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