Optic Nerve Sheath Diameter in Hypertensive Emergency (OpticUS)

October 8, 2024 updated by: Tessa Mulder, Leiden University Medical Center

Point-of-care Ultrasound of Optic Nerve Sheath Diameter in Suspected Hypertensive Emergency

This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

375

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 Contact Backup

  • Name: Martijn Bauer, MD, PhD
  • Phone Number: +31 71 52 62381
  • Email: m.p.bauer@lumc.nl

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the emergency department with suspected hypertensive emergency.

Description

Inclusion Criteria:

  • ≥ 18 years old
  • Any patient presenting to the emergency department (ED) with suspected hypertensive emergency i.e.: blood pressure of > 200 millimetres of mercury (mmHg) systolic and/or > 120 mmHg diastolic

Exclusion Criteria:

  • Patients with preexisting optic nerve head changes such as glaucoma, pre-existing retinal artery/vein occlusions or any other condition that makes assessment of the fundi impossible.
  • Primary neurological cause of hypertension: ischemic cerebrovascular incident

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Papilledema
Time Frame: 2 years
Sensitivity of ONSD > 5mm for diagnosis of papilledema
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertensive retinopathy grade 3 & 4 combined
Time Frame: 2 years
Sensitivity/specificity of the ONSD for hypertensive retinopathy grade 3 & 4 combined
2 years
Hypertensive encephalopathy
Time Frame: 2 years
Sensitivity/specificity of the ONSD for hypertensive encephalopathy
2 years
Rapid acting medications administered intravenously to lower the elevated blood pressure
Time Frame: 2 years
Sensitivity/specificity of the ONSD for the need for rapid acting medications administered intravenously to lower the elevated blood pressure
2 years
Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve
Time Frame: 2 years
Diagnostic characteristics for the presence of a bulging optic nerve disc and/or crescent sign for above mentioned diagnoses (papilledema, hypertensive retinopathy grade 3&4 combined, hypertensive encephalopathy, need for rapid acting intravenous medications to lower elevated bloodpressure).
2 years

Collaborators and Investigators

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

Sponsor

Leiden University Medical Center

Investigators

  • Principal Investigator: Tessa Mulder, MD, Leiden University Medical Center

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 (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL84914.058.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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