Randomized Controlled Trial on Nystagmus Assessment for Patients Consulting for Acute Vertigo in the Emergency Department With/Without Frenzel Lens With/Without Form: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- Rate of Nystagmus detection per participant
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Frenzel Lens with 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
Intervention: Frenzel Lens (Device)
Frenzel Lens with 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
Intervention: Diagnostic Algorithm (Diagnostic Test)
Frenzel Lens without Diagnostic Algorithm
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.
Intervention: Frenzel Lens (Device)
No Frenzel Lens with 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
Intervention: Diagnostic Algorithm (Diagnostic Test)
No Frenzel Lens and No Diagnostic Algorithm
The emergency physician is performing the assessment of nystagmus and its interpretation as usual. The Frenzel lens and the diagnostic algorithm are not used.
Outcomes
Primary Outcomes
Rate of Nystagmus detection per participant
Time Frame: 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 Outcomes
- Rate of acute stroke per participant(From day 0 to 12 weeks)
- Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant(From day 0 t0 12 weeks)
- Adverse Events(From day 0 to 12 weeks)
- Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance(Day 0)
- Emergency Department Length of stay(Day 0, from triage time to Emergency Department departure (admission or home discharge))
- Rate of specialised consultations for vertigo/dizziness/imbalance per participant(From day 0 to 12 weeks)
- Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant(From day 0 to 12 weeks)
- Rate of symptomatic central lesion per participant(From day 0 to 12 weeks)
- Rate of the use of Particles Repositioning Technique(Day 0)
- Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus(From day 0 to 12 weeks)
- Rate of neuro-imaging per participant(From day 0 to 12 weeks)
- Rate of New Atrial Fibrillation(From day 0 to 12 weeks)
- Rate of New Stroke at 12 weeks(At 12 weeks)
Investigators
Pierre La Rochelle
Chief Investigator
CHU de Quebec-Universite Laval