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NCT Number: NCT06286696

Optic Nerve Sheath Diameter in 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.

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Key information

Conditions

Hypertensive Emergency Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Hypertension Hypertensive Crisis Nervous System Diseases Optic Nerve Diseases Papilledema Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optic Nerve Sheath Diameter

Diagnostic Test

Point of care ultrasonography of the optic nerve sheath diameter

Primary outcomes

  1. Papilledema

    Time frame: 2 years

    Sensitivity of ONSD > 5mm for diagnosis of papilledema

Secondary outcomes

  1. Hypertensive retinopathy grade 3 & 4 combined

    Time frame: 2 years

    Sensitivity/specificity of the ONSD for hypertensive retinopathy grade 3 & 4 combined

  2. Hypertensive encephalopathy

    Time frame: 2 years

    Sensitivity/specificity of the ONSD for hypertensive encephalopathy

  3. 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

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Martijn Bauer, MD, PhD

CONTACT

[email protected]

+31 71 52 62381

Tessa Mulder, MD

CONTACT

[email protected]

+31 71 52 96151

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Acronym: OpticUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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