Optic Nerve Sheath Diameter in Hypertensive Emergency
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
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
Trial population
Patients presenting to the emergency department with suspected hypertensive emergency.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Optic Nerve Sheath Diameter
Diagnostic testPoint of care ultrasonography of the optic nerve sheath diameter
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Papilledema
Sensitivity of ONSD \> 5mm for diagnosis of papilledema
Time frame
2 yearsSecondary outcomes
1
Hypertensive retinopathy grade 3 & 4 combined
Sensitivity/specificity of the ONSD for hypertensive retinopathy grade 3 \& 4 combined
Time frame
2 years2
Hypertensive encephalopathy
Sensitivity/specificity of the ONSD for hypertensive encephalopathy
Time frame
2 years3
Rapid acting medications administered intravenously to lower the elevated blood pressure
Sensitivity/specificity of the ONSD for the need for rapid acting medications administered intravenously to lower the elevated blood pressure
Time frame
2 years4
Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve
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).
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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