Optic Nerve Sheath Diameter in Hypertensive Emergency

Not yet recruiting

• Conditions: Hypertensive Emergency; Papilledema; Hypertension

• Registration Number: NCT06286696
• Lead Sponsor: Leiden University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Study Start: 2024-11-01
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 375

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Papilledema	2 years	Sensitivity of ONSD \> 5mm for diagnosis of papilledema

Secondary Outcome Measures

Name	Time	Method
Hypertensive encephalopathy	2 years	Sensitivity/specificity of the ONSD for hypertensive encephalopathy
Hypertensive retinopathy grade 3 & 4 combined	2 years	Sensitivity/specificity of the ONSD for hypertensive retinopathy grade 3 \& 4 combined
Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve	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).
Rapid acting medications administered intravenously to lower the elevated blood pressure	2 years	Sensitivity/specificity of the ONSD for the need for rapid acting medications administered intravenously to lower the elevated blood pressure