Clincosm LogoSign in Get a demo

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

Sponsor
The First Hospital of Jilin University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04981548
Collaborator
(none)
1,000
Enrollment
1
Location
11.8
Anticipated Duration (Months)
84.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: a Chinese Multicenter Study
Actual Study Start Date :
Nov 6, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 the first hospital of Jilin university Changchun Jilin China 1300021

Sponsors and Collaborators

  • The First Hospital of Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
LIJUAN WANG, associate professor, The First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT04981548
Other Study ID Numbers:
  • 21K081-001
First Posted:
Jul 29, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by LIJUAN WANG, associate professor, The First Hospital of Jilin University
optic nerve sheath diameter
intracranial pressure
Additional relevant MeSH terms:
Intracranial Hypertension

Study Results

No Results Posted as of Apr 6, 2022