Nystagmus Assessment for Patients Consulting in the Emergency Department for Acute Vertigo
- Conditions
- Nystagmus, AcquiredStroke, Acute
- Interventions
- Device: Frenzel LensDiagnostic Test: Diagnostic Algorithm
- Registration Number
- NCT05176015
- Lead Sponsor
- CHU de Quebec-Universite Laval
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- New episode of acute vertigo/dizziness/imbalance occuring during the 28 last days
- Must be able to consent.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Frenzel Lens with Diagnostic Algorithm Frenzel Lens Frenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and if present describe its main characteristic. Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging No Frenzel Lens with Diagnostic Algorithm Diagnostic Algorithm Nystagmus assessment in different manoeuvres is performed without the use of Frenzel lens. Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging Frenzel Lens without Diagnostic Algorithm Frenzel Lens Frenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and describe its main characteristics. No diagnostic algorithm will be used to interpret nystagmus. Frenzel Lens with Diagnostic Algorithm Diagnostic Algorithm Frenzel lens will be applied on patients' eyes during different diagnostic maneuvers to assess if a nystagmus is present and if present describe its main characteristic. Without mentioning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
Adverse Events From day 0 to 12 weeks Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy
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.
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 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 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 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
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 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,
Trial Locations
- Locations (5)
Centre Hospitalier d'Amqui
🇨🇦Amqui, Quebec, Canada
Hopital Notre-Dame-de-Fatima
🇨🇦La Pocatiere, Quebec, Canada
Centre Hospitalier de Matane
🇨🇦Matane, Quebec, Canada
Hopital St-Georges
🇨🇦St-Georges, Quebec, Canada
Centre Hospitalier de Montmagny
🇨🇦Montmagny, Quebec, Canada