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

July 22, 2023 updated by: LIJUAN WANG, The First Hospital of Jilin University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 1300021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
raised intracranial pressure
more than 200 mmH2O
Other: no intervention
no intervention
the normal intracranial pressure group
more than 80 mmH2O and no more than 200 mmH2O
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The normal range of ONSD in healthy Chinese adults.
Time Frame: 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.
2021.8-2022.8
determine the ONSD cut-off point for high intracranial pressure.
Time Frame: 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.
2021.8-2022.8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2021

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21K081-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the study protocal wil be shared with other researchers.

IPD Sharing Time Frame

the study protocal will become available on December 2022 and for 2 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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