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

Recruiting

• Conditions: Ultrasonography
• Interventions: Other: no intervention

• Registration Number: NCT04981548
• Lead Sponsor: The First Hospital of Jilin University

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.

Detailed 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) .

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-29
• Study Start: 2021-11-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-22
• Last Update Posted: 2023-07-25
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
raised intracranial pressure	no intervention	more than 200 mmH2O
the normal intracranial pressure group	no intervention	more than 80 mmH2O and no more than 200 mmH2O

Primary Outcome Measures

Name	Time	Method
The normal range of ONSD in healthy Chinese adults.	2021.8-2022.8	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.
determine the ONSD cut-off point for high intracranial pressure.	2021.8-2022.8	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.

Trial Locations

Locations (1)

the first hospital of Jilin university; 🇨🇳 Changchun, Jilin, China