Optic Nerve Sheath Diameter in Hypertensive Emergency

Hypertension Clinical Trial

— OpticUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286696
• Other study ID #: NL84914.058.23
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: Leiden University Medical Center
• Contact: Tessa Mulder, MD
• Phone: +31 71 52 96151
• Email: t.a.mulder[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 375
• Est. completion date: July 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hypertension
• Hypertension, Malignant
• Hypertensive Crisis
• Hypertensive Emergency
• Papilledema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Papilledema	Sensitivity of ONSD > 5mm for diagnosis of papilledema	2 years
Secondary	Hypertensive retinopathy grade 3 & 4 combined	Sensitivity/specificity of the ONSD for hypertensive retinopathy grade 3 & 4 combined	2 years
Secondary	Hypertensive encephalopathy	Sensitivity/specificity of the ONSD for hypertensive encephalopathy	2 years
Secondary	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	2 years
Secondary	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).	2 years