External Validation of VAN, VES and LARIO Scales in Suspected Acute Stroke

NCT06024330 | Completed DMC

• 1 other identifier: KU GOEK-2022/06.15
• Study Type: observational
• Target: 614
• Locations: 1 country
• Sites: 1

Brief Summary

In acute ischemic stroke, treatments include intravenous thrombolysis (IVT) and mechanical thrombectomy (MT). IVT is viable up to 4.5 hours post-stroke onset, while MT is applicable within 24 hours but primarily for large vessel occlusions. MT is specialized and performed in select stroke centers. Effective early triage improves neurological outcomes. Pre-hospital stroke severity assessment and direct transfers for MT are crucial. Although the National Institute of Health Stroke Scale (NIHSS) is widely recognized, its practicality is limited in emergency settings due to its complexity. Alternative scoring systems like LAMS, CPSS, and RACE have been introduced but have limitations. Recently developed scores, namely Vision, Aphasia, and Neglect (VAN), Ventura Emergency Large Vessel Occlusion (VES), and Large Artery Intracranial Occlusion Stroke Scale (LARIO), demonstrate promising diagnostic accuracy in pilot studies, suggesting potential benefits for early detection, appropriate triage, and better neurological outcomes

Conditions

Stroke

Keywords

Triage; Emergency Departments; Stroke; Scales

Outcome Measures

Primary Outcomes (3)

• Diagnostic performance of VAN for predicting ELVO

  Sensitivity, specificity, PPV, NPV

  24 hours

• Diagnostic performance of VES for predicting ELVO

  Sensitivity, specificity, PPV, NPV

  24 hours

• Diagnostic performance of LARIO for predicting ELVO

  Sensitivity, specificity, PPV, NPV

  24 hours

Secondary Outcomes (1)

• Diagnostic performance of NIHSS for predicting ELVO

  24 hours

Study Arms (6)

Positive VAN scale

Motor Function: Check for arm drift with arms extended, palms up, and eyes closed for 10 seconds. If present, proceed to the VAN criteria. V (Visual): Assess for reported double vision, field cut, or vision loss, or difficulty seeing fingers in a quadrant. If any visual disturbances are found, the patient is "VAN positive". A (Aphasia): Identify difficulties forming words, repeating a short sentence, recognizing two objects, or following simple commands. If any aphasia symptoms are observed, the patient is "VAN positive". N (Neglect): Check for forced gaze, inability to track a pen to one side, or lack of sensation in limbs. If any neglect signs are detected, the patient is "VAN positive".

Diagnostic Test: VAN assessment

Negative VAN scale

A negative VAN scale indicates that a potential stroke patient does not exhibit the primary signs associated with a large vessel occlusion (LVO). Specifically, the patient demonstrated no arm drift during the initial motor function test. If the motor assessment is proceeded to the VAN criteria, the patient shows no visual disturbances like double vision or field cuts ("V"), no aphasia symptoms such as difficulty forming words or repeating sentences ("A"), and no signs of neglect, like forced gaze or lack of sensation in limbs ("N")

Diagnostic Test: VAN assessment

Positive VES scale

Eye Deviation: Scored as 1 if there's a forced deviation of both eyes to any side; otherwise, scored as 0. Aphasia: Scored as 1 if the patient is awake and exhibits one or more of the following: Inability to repeat a sentence. Inability to name an object. Talking incoherently or not obeying commands. Being mute. Otherwise, scored as 0. Neglect: Scored as 1 if the patient can perceive touch on both sides individually but fails to feel it on one side when stimulated simultaneously. Otherwise, scored as 0. Obtundation: Scored as 1 if the patient cannot maintain wakefulness during a conversation; otherwise, scored as 0. The VES can range from 0 to 4. A score of 1 or higher suggests a positive likelihood for ELVO. Additionally, if a patient tests positive for aphasia, neglect can be deduced by noting if the patient disregards the examiner on one side but is responsive when the examiner switches sides.

Diagnostic Test: VES assessment

Negative VES scale

Eye Deviation: No forced deviation of both eyes is observed. Aphasia: The patient, while awake, can repeat sentences, name objects, speaks coherently, follows commands, and is not mute. Neglect: The patient can perceive touch both when sides are stimulated individually and simultaneously. Obtundation: The patient remains awake and alert during conversation. A total score of 0 on the VES scale represents a VES negative outcome.

Diagnostic Test: VES assessment

Positive LARIO scale

Facial Palsy: The presence of facial muscle weakness or paralysis scores 1, while a normal facial expression scores 0. Arm Weakness: A score of 1 is given for arm drift, no effort against gravity, or no movement at all. No drift is scored 0. Grip Strength: Reduced or absent grip strength scores 1, while a normal grip scores 0. Language: Changes in speech, global aphasia, or the patient being mute results in a score of 1. Normal language is scored 0. Neglect: A score of 1 is given if the patient exhibits extinction to bilateral simultaneous stimulation in one or more sensory modality, doesn't recognize their own hand, or consistently orients only to one side of the body. The absence of these signs scores 0. A cumulative score exceeding 3 on the LARIO Stroke Scale categorizes the patient as "LARIO positive,"

Diagnostic Test: LARIO assessment

Negative LARIO scale

Facial Palsy: No observable facial muscle weakness or paralysis. Arm Weakness: The arm remains steady without drift and exhibits normal effort against gravity. Grip Strength: The patient displays normal grip strength. Language: The patient speaks normally, without aphasia or muteness. Neglect: No signs of sensory extinction upon bilateral simultaneous stimulation, proper recognition of their own hand, and balanced orientation to both sides of the body. A cumulative score of 3 or less on the LARIO Stroke Scale classifies the patient as "LARIO negative,"

Diagnostic Test: LARIO assessment

Interventions

VAN assessment DIAGNOSTIC_TEST

An investigator assesses the VAN scale when a patient arrives at ED triage with a suspected stroke.

Negative VAN scale; Positive VAN scale

VES assessment DIAGNOSTIC_TEST

An investigator assesses the VES scale when a patient arrives at ED triage with a suspected stroke.

Negative VES scale; Positive VES scale

LARIO assessment DIAGNOSTIC_TEST

An investigator assesses the LARIO scale when a patient arrives at ED triage with a suspected stroke.

Negative LARIO scale; Positive LARIO scale

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients with a suspicion of stroke who were admitted to the ED by EMS.

You may qualify if:

• Adult patients admitted to the ED with the suspicion of stroke by EMS.

You may not qualify if:

• More than 24 hours have passed since the onset of symptoms or the last known normal in the patient.
• The emergency physician does not indicate the need for imaging like Computerized Tomography (CT), CT Angiography (CTA), Diffusion-Weighted Magnetic Resonance Imaging (DWI-MRI), or Magnetic Resonance Angiography (MRA), or the imaging test cannot be performed.
• Exacerbation of residual symptoms due to a previous hemorrhagic or ischemic stroke.
• Conditions in the ED that prevent scale assessment (e.g., advanced airway needs, the patient's non-cooperation with the examination, immediate resuscitation need, etc.).
• Patients transferred to ED after being diagnosed at another healthcare institution.
• Pregnant patients
• Non-consenting patients.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

İzmit, Kocaeli, 41100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Emergencies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

TU (1)