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Not yet recruiting NCT06286696

Optic Nerve Sheath Diameter in Hypertensive Emergency

Observational Hypertensive Emergency Papilledema Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optic Nerve Sheath Diameter.
Who it may be relevant to
Registry conditions: Hypertensive Emergency, Papilledema, Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Diagnostic test Optic Nerve Sheath Diameter
    Point of care ultrasonography of the optic nerve sheath diameter

Primary outcome measures

  • Papilledema [Time frame: 2 years]
Secondary outcome measures (4)
  • Hypertensive retinopathy grade 3 & 4 combined [Time frame: 2 years]
  • Hypertensive encephalopathy [Time frame: 2 years]
  • Rapid acting medications administered intravenously to lower the elevated blood pressure [Time frame: 2 years]
  • Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06286696 · NL84914.058.23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗