Nystagmus Assessment for Patients Consulting in the Emergency Department for Acute Vertigo

Stroke, Acute Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05176015
• Other study ID #: MP-CIBSSSBSL-2021-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Emergencies
• Nystagmus, Acquired
• Stroke
• Stroke, Acute
• Vertigo

Intervention

Device:
• Frenzel 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 Test:
• Diagnostic 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

Locations

Country	Name	City	State
Canada	Centre Hospitalier d'Amqui	Amqui	Quebec
Canada	Hopital Notre-Dame-de-Fatima	La Pocatiere	Quebec
Canada	Centre Hospitalier de Matane	Matane	Quebec
Canada	Centre Hospitalier de Montmagny	Montmagny	Quebec
Canada	Hopital St-Georges	St-Georges	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Nystagmus detection per participant	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)	Day 0
Secondary	Emergency Department Length of stay	Time spent at the emergency department from triage to time of departure for hospital admission or for home discharge assessed up to 48 hours	Day 0, from triage time to Emergency Department departure (admission or home discharge)
Secondary	Rate of neuro-imaging per participant	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.	From day 0 to 12 weeks
Secondary	Rate of acute stroke per participant	Any acute stroke, hemorrhagic or ischemic, diagnosed by neuro-imaging: computed tomography or magnetic resonance imaging	From day 0 to 12 weeks
Secondary	Rate of symptomatic central lesion per participant	Any central lesion diagnosed by computed tomography or magnetic resonance imaging that may be related to the initial presentation of vertigo/dizziness/imbalance	From day 0 to 12 weeks
Secondary	Rate of specialised consultations for vertigo/dizziness/imbalance per participant	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.	From day 0 to 12 weeks
Secondary	Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant	Admission to hospital directly related to vertigo/dizziness/imbalance may be immediate to initial visit or delayed.	From day 0 to 12 weeks
Secondary	Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant	Return visit to the emergency department for vertigo/dizziness/imbalance as chief complaint.	From day 0 t0 12 weeks
Secondary	Rate of New Atrial Fibrillation	Atrial fibrillation detected by the initial visit electrocardiogram or by long-term cardiac rhythm monitoring (Holter or loop recorder).	From day 0 to 12 weeks
Secondary	Rate of New Stroke 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,	At 12 weeks
Secondary	Rate of the use of Particles Repositioning Technique	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.	Day 0
Secondary	Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus	Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus: direction, duration	From day 0 to 12 weeks
Secondary	Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance	Simple question answered on a likert scale at the end of the ED encounter. 0% worst, 100% best appreciation.	Day 0
Secondary	Adverse Events	Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy	From day 0 to 12 weeks