search
Back to results

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

Primary Purpose

Nystagmus, Acquired, Stroke, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Frenzel Lens
Diagnostic Algorithm
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nystagmus, Acquired focused on measuring nystagmus, stroke, neuroimaging, cardiovascular disease, benign positional paroxystic vertigo

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • New episode of acute vertigo/dizziness/imbalance occuring during the 7 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 fluently in French or English.
  • Reachable for 3 month follow-up

Sites / Locations

  • Centre Hospitalier d'AmquiRecruiting
  • Hopital Notre-Dame-de-Fatima
  • Centre Hospitalier de MataneRecruiting
  • Centre Hospitalier de MontmagnyRecruiting
  • Hopital St-GeorgesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Frenzel Lens with Diagnostic Algorithm

Frenzel Lens without Diagnostic Algorithm

No Frenzel Lens with Diagnostic Algorithm

No Frenzel Lens and No Diagnostic Algorithm

Arm Description

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

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.

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

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 Outcome Measures

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)

Secondary Outcome Measures

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
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.
Rate of acute stroke per participant
Any acute stroke, hemorrhagic or ischemic, diagnosed by neuro-imaging: computed tomography or magnetic resonance imaging
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
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.
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.
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.
Rate of New Atrial Fibrillation
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
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
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
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
Simple question answered on a likert scale at the end of the ED encounter. 0% worst, 100% best appreciation.
Adverse Events
Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy

Full Information

First Posted
October 19, 2021
Last Updated
August 29, 2023
Sponsor
CHU de Quebec-Universite Laval
search

1. Study Identification

Unique Protocol Identification Number
NCT05176015
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nystagmus, Acquired, Stroke, Acute
Keywords
nystagmus, stroke, neuroimaging, cardiovascular disease, benign positional paroxystic vertigo

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Frenzel Lens with Diagnostic Algorithm
Arm Type
Experimental
Arm Description
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
Arm Title
Frenzel Lens without Diagnostic Algorithm
Arm Type
Experimental
Arm Description
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.
Arm Title
No Frenzel Lens with Diagnostic Algorithm
Arm Type
Experimental
Arm Description
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
Arm Title
No Frenzel Lens and No Diagnostic Algorithm
Arm Type
No Intervention
Arm Description
The emergency physician is performing the assessment of nystagmus and its interpretation as usual. The Frenzel lens and the diagnostic algorithm are not used.
Intervention Type
Device
Intervention Name(s)
Frenzel Lens
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic Algorithm
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of Nystagmus detection per participant
Description
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)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Emergency Department Length of stay
Description
Time spent at the emergency department from triage to time of departure for hospital admission or for home discharge assessed up to 48 hours
Time Frame
Day 0, from triage time to Emergency Department departure (admission or home discharge)
Title
Rate of neuro-imaging per participant
Description
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.
Time Frame
From day 0 to 12 weeks
Title
Rate of acute stroke per participant
Description
Any acute stroke, hemorrhagic or ischemic, diagnosed by neuro-imaging: computed tomography or magnetic resonance imaging
Time Frame
From day 0 to 12 weeks
Title
Rate of symptomatic central lesion per participant
Description
Any central lesion diagnosed by computed tomography or magnetic resonance imaging that may be related to the initial presentation of vertigo/dizziness/imbalance
Time Frame
From day 0 to 12 weeks
Title
Rate of specialised consultations for vertigo/dizziness/imbalance per participant
Description
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.
Time Frame
From day 0 to 12 weeks
Title
Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant
Description
Admission to hospital directly related to vertigo/dizziness/imbalance may be immediate to initial visit or delayed.
Time Frame
From day 0 to 12 weeks
Title
Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant
Description
Return visit to the emergency department for vertigo/dizziness/imbalance as chief complaint.
Time Frame
From day 0 t0 12 weeks
Title
Rate of New Atrial Fibrillation
Description
Atrial fibrillation detected by the initial visit electrocardiogram or by long-term cardiac rhythm monitoring (Holter or loop recorder).
Time Frame
From day 0 to 12 weeks
Title
Rate of New Stroke at 12 weeks
Description
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,
Time Frame
At 12 weeks
Title
Rate of the use of Particles Repositioning Technique
Description
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.
Time Frame
Day 0
Title
Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus
Description
Rate of Emergency Department Visit Return for Benign Paroxysmal Positional Vertigo according to Typical Nystagmus: direction, duration
Time Frame
From day 0 to 12 weeks
Title
Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance
Description
Simple question answered on a likert scale at the end of the ED encounter. 0% worst, 100% best appreciation.
Time Frame
Day 0
Title
Adverse Events
Description
Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy
Time Frame
From day 0 to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre La Rochelle, MD, MSc
Phone
418-856-7000
Email
pierre.la-rochelle.med@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre La Rochelle, MD, MSc
Organizational Affiliation
Universite Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier d'Amqui
City
Amqui
State/Province
Quebec
ZIP/Postal Code
G5J 2K5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommy Bélanger-Lizotte, MD
Phone
418-629-2211
Email
tommy.belanger-lizotte.med@ssss.gouv.qc.ca
Facility Name
Hopital Notre-Dame-de-Fatima
City
La Pocatiere
State/Province
Quebec
ZIP/Postal Code
G0R 1Z0
Country
Canada
Individual Site Status
Completed
Facility Name
Centre Hospitalier de Matane
City
Matane
State/Province
Quebec
ZIP/Postal Code
G4W 2W5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Séguin, MD
Phone
418-562-3135
Email
antoine.seguin.med@ssss.gouv.qc.ca
Facility Name
Centre Hospitalier de Montmagny
City
Montmagny
State/Province
Quebec
ZIP/Postal Code
G5V 3R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Bilodeau, MD
Phone
418-456-4897
Email
samuel.bilodeau.med@ssss.gouv.qc.ca
Facility Name
Hopital St-Georges
City
St-Georges
State/Province
Quebec
ZIP/Postal Code
G5Y4T8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cedric Giguere, MD
Phone
581-996-6459
Email
cedric.giguere.med@ssss.gouv.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs