Nystagmus, Acquired, Stroke, Acute
Conditions
Keywords
nystagmus, stroke, neuroimaging, cardiovascular disease, benign positional paroxystic vertigo
Brief summary
This pilot study is perfomed to validate and document faisability of the use of Frenzel lens and the use of a diagnostic algorithm for the assessment of a special sign (nystagmus) observe in the eyes of patients consulting in the emergency department (ED) for an acute episode of vertigo/dizziness/imbalance.
Detailed description
This pilot study is a randomized controlled trial 2 by 2 design to allocated randomly the Frenzel lens and the diagnostic algorithm. There is no use of sham lens. The usual care opposed to the diagnostic algorithm will be questioned only on the perception of nystagmus by the clinician and the use of repositioning particles technique. The only blinding will be the patients about the use of the algorithm and the outcomes assessor about the use or not of Frenzel lens and the use or not of the diagnostic algorithm.
Interventions
DEVICEFrenzel Lens
pair of magnifying glasses (+20 dioptres) that are worn by the patient and an illuminating system. On using Frenzel goggles, the nystagmus is better seen as a result of eyes being magnified and inhibition of visual fixation.
DIAGNOSTIC_TESTDiagnostic Algorithm
A diagnostic algorithm using the TiTrate approach: continuous, Intermittent, trigger or spontaneous. The diagnostic algorithm use the REDCap software that include different videos to illustrate diagnostic tests and nystagmus types. Different maneuvers: HINTS+ battery, Dix-Hallpike test, Supine Roll test. Different Particle Repositioning Techniques will be proposed according to specific tests: Epley and Gufoni maneuvers. Risk Score is used to assess stroke risk for transient ischaemic attack (TIA): ABCD2 and the Canadian TIA Risk Score
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* New episode of acute vertigo/dizziness/imbalance occuring during the 28 last days * Must be able to consent.
Exclusion criteria
* No traumatic context before symptoms onset * No intoxication context * Glycemia ≤ 3,0 mmol/L * Only one participation is permitted * Not able to speak adequately in French or English. * Reachable for 3 month follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Nystagmus detection per participant | Day 0 | During eye examination, nystagmus will be characterized according to prominent direction of the fast phase (patients' left, patients' right, up, down, rotational),with their clinical setting or trigger. Overall rate of nystagmus detection by participant. (Rate of typical nystagmus for benign paroxysmal positional vertigo in the Dix-Hallpike maneuver or Supine Head Roll Test. Rate of nystagmus detection in the initial physical exam) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Length of stay | Day 0, from triage time to Emergency Department departure (admission or home discharge) | Time spent at the emergency department from triage to time of departure for hospital admission or for home discharge assessed up to 48 hours |
| Rate of neuro-imaging per participant | From day 0 to 12 weeks | Any imaging to investigate acute intra-cerebral lesion and/or the neck/brain vascular. anomaly : computed tomography imaging; computed tomography angiogram; magnetic resonance angiography; magnetic resonance imaging, vascular neck ultrasound imaging. |
| Rate of acute stroke per participant | From day 0 to 12 weeks | Any acute stroke, hemorrhagic or ischemic, diagnosed by neuro-imaging: computed tomography or magnetic resonance imaging |
| Rate of symptomatic central lesion per participant | From day 0 to 12 weeks | Any central lesion diagnosed by computed tomography or magnetic resonance imaging that may be related to the initial presentation of vertigo/dizziness/imbalance |
| Rate of specialised consultations for vertigo/dizziness/imbalance per participant | From day 0 to 12 weeks | Any specialised consultations (neurology, ear nose and throat (ENT), cardiology or similar) to investigate the acute vertigo/dizziness/imbalance with the final diagnosis. Sumarisation of final diagnosis. |
| Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant | From day 0 to 12 weeks | Admission to hospital directly related to vertigo/dizziness/imbalance may be immediate to initial visit or delayed. |
| Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant | From day 0 t0 12 weeks | Return visit to the emergency department for vertigo/dizziness/imbalance as chief complaint. |
| Rate of New Atrial Fibrillation | From day 0 to 12 weeks | Atrial fibrillation detected by the initial visit electrocardiogram or by long-term cardiac rhythm monitoring (Holter or loop recorder). |
| Rate of New Stroke at 12 weeks | At 12 weeks | A stroke free status will be assessed by a validated questionnaire by telephone at tree months and all specialised consultations and neuroimaging will be reviewed for acute stroke diagnosis, |
| Rate of the use of Particles Repositioning Technique | Day 0 | Once Paroxysmal Positional Vertigo diagnosis is being diagnosed with the Dix-Hallpike test or with the Supine Head Roll test, the use of particles repositioning technique, Epley or Gufoni maneuvers, will be noted with their immediate impact on acute vertigo. |
| Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus | From day 0 to 12 weeks | Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus: direction, duration |
| Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance | Day 0 | Simple question answered on a likert scale at the end of the ED encounter. 0% worst, 100% best appreciation. |
| Adverse Events | From day 0 to 12 weeks | Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORPierre La Rochelle, MD, MSc
Universite Laval
Outcome results
None listed