External Validation of VAN, VES and LARIO Scales in Suspected Acute Stroke
NCT ID: NCT06024330
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
614 participants
OBSERVATIONAL
2023-06-01
2023-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Enhancing Prehospital Stroke Diagnosis
NCT06427746
EEG Controlled Triage in the Ambulance for Acute Ischemic Stroke
NCT03699397
Prehospital Prediction of Large Anterior Vessel Occlusion
NCT04442659
Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting
NCT06332989
Triage of Patients Presenting Beyond 24 Hours With Acute Ischemic Stroke Due to Large Vessel Occlusions (TRACK-LVO Late)
NCT06200753
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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".
VAN assessment
An investigator assesses the VAN scale when a patient arrives at ED triage with a suspected stroke.
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")
VAN assessment
An investigator assesses the VAN scale when a patient arrives at ED triage with a suspected stroke.
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.
VES assessment
An investigator assesses the VES scale when a patient arrives at ED triage with a suspected stroke.
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.
VES assessment
An investigator assesses the VES scale when a patient arrives at ED triage with a suspected stroke.
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,"
LARIO assessment
An investigator assesses the LARIO scale when a patient arrives at ED triage with a suspected stroke.
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,"
LARIO assessment
An investigator assesses the LARIO scale when a patient arrives at ED triage with a suspected stroke.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VAN assessment
An investigator assesses the VAN scale when a patient arrives at ED triage with a suspected stroke.
VES assessment
An investigator assesses the VES scale when a patient arrives at ED triage with a suspected stroke.
LARIO assessment
An investigator assesses the LARIO scale when a patient arrives at ED triage with a suspected stroke.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kocaeli University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ibrahim Ulas Ozturan
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kocaeli University
İzmit, Kocaeli, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KU GOEK-2022/06.15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.