Clinical trial NCT05176015: Nystagmus Assessment for Patients Consulting in the Emergency Department for Acute Vertigo
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nystagmus, Acquired
Stroke, Acute
Keywords: nystagmus
stroke
neuroimaging
cardiovascular disease
benign positional paroxystic vertigo
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Nystagmus detection per participant
timeFrame: Day 0
Secondary outcomes:
measure: Emergency Department Length of stay
timeFrame: Day 0, from triage time to Emergency Department departure (admission or home discharge)
measure: Rate of neuro-imaging per participant
timeFrame: From day 0 to 12 weeks
measure: Rate of acute stroke per participant
timeFrame: From day 0 to 12 weeks
measure: Rate of symptomatic central lesion per participant
timeFrame: From day 0 to 12 weeks
measure: Rate of specialised consultations for vertigo/dizziness/imbalance per participant
timeFrame: From day 0 to 12 weeks
measure: Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant
timeFrame: From day 0 to 12 weeks
measure: Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant
timeFrame: From day 0 t0 12 weeks
measure: Rate of New Atrial Fibrillation
timeFrame: From day 0 to 12 weeks
measure: Rate of New Stroke at 12 weeks
timeFrame: At 12 weeks
measure: Rate of the use of Particles Repositioning Technique
timeFrame: Day 0
measure: Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus
timeFrame: From day 0 to 12 weeks
measure: Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance
timeFrame: Day 0
measure: Adverse Events
timeFrame: From day 0 to 12 weeks
Other outcomes:
Locations:
city: Amqui
country: Canada
facility: Centre Hospitalier d'Amqui
state: Quebec
city: La Pocatiere
country: Canada
facility: Hopital Notre-Dame-de-Fatima
state: Quebec
city: Matane
country: Canada
facility: Centre Hospitalier de Matane
state: Quebec
city: Montmagny
country: Canada
facility: Centre Hospitalier de Montmagny
state: Quebec
city: St-Georges
country: Canada
facility: Hopital St-Georges
state: Quebec
Study officials:
affiliation: Universite Laval
name: Pierre La Rochelle, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: