Clinical trial: Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT) (NCT02483429)

Eligibility criteria:
Inclusion criteria:

        Adult (18 years and older) ED patients with all of the following (all determined
        pre-randomization):

        VESTIBULAR SYMPTOMS: presenting symptom of "vertigo" OR "dizziness" OR "unsteadiness" (as
        defined by consensus expert definitions in the International Classification of Vestibular
        Disorders).

        RELEVANT EXAM SIGNS*: pathologic nystagmus (spontaneous, gaze-evoked, or positional) by
        bedside VOG testing OR pathologic ataxia (gait, trunk, stance, limbs) by bedside ataxia
        examination.

        RECENT ONSET: symptoms AND signs* appear to be new or markedly worse in the past month

        * Exam signs are required for randomization, but not for the observational arm

        Exclusion Criteria

          1. Excluded from Pre-Randomization Screening

             Level 1 trauma or critical illness Altered mental status (e.g., delirium, dementia)
             that would preclude active study participation (this includes patients with abnormal
             mental state due to alcohol intoxication or illicit substance, which are known,
             easily-recognized causes of dizziness or vertigo presentations to the ED) Non-English
             speaking (enrollment of non-English speakers is not feasible given the logistics of
             identifying a translator and the need for rapid recruitment and randomization in the
             AVERT study; furthermore, the terms vertigo, dizziness, and unsteadiness may have
             different meanings in other languages) Known pregnancy (all women of childbearing age
             who are enrolled will undergo a urine or serum beta-HCG pregnancy test prior to MRI to
             confirm no pregnancy, per local institutional guidelines)

             Unable or unsafe to participate in screening, including VOG tests (as deemed by
             specific pre-enrollment risk assessment questions or ED provider and/or Study
             Coordinator judgment) including, but not limited to:

             visual impairment sufficient to prevent visual fixation during the VOG testing
             clinically-perceived risk to patient of participating in study (ED provider or staff
             concerns) clinically-perceived risk to research staff (e.g., violence, blood/body
             fluid/respiratory precautions) unstable cardiac status (given a single reported case
             of bradycardia with impulse testing) acute cranio-cervical trauma or other condition
             (e.g., rheumatoid arthritis) that might lead to instability of the cervical spine that
             would be a contraindication to neck rotation during VOG testing Obvious general
             medical cause (as judged by treating ED provider) including, but not limited to, acute
             myocardial infarction, pulmonary embolus, pneumonia, urinary tract infection, drug
             intoxication, etc.

          2. Excluded from Randomization (Eligible for Observational Arm Follow-up)

        Patient previously randomized in the AVERT Trial (previously screened but not randomized
        are eligible)

        Unable to participate fully with study follow-up (particularly MRI) including, but not
        limited to:

        unable to return for follow-up testing within 30 days unable to undergo MRI because of
        contraindications (e.g., pacemaker, metallic foreign body, pregnancy) or other reasons
        (severe claustrophobia, too large or too heavy for MRI scanner)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Entailment