Impact of a Magnetic Resonance Imaging (MRI) Scanner Exclusively Dedicated to Emergency in the Clinical Management of Patients Presenting With Diplopia or Dizziness

Completed

• Conditions: Stroke; Dizziness; Diplopia; Emergency Department; MRI

• Registration Number: NCT03660852
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

IRM-DU is a prospective observational single center study conducted in an emergency department to evaluate the impact of a MRI scanner exclusively dedicated to emergency in the clinical management of patients presenting with dizziness or diplopia.

The study will compare 2 strategies : after and before availability of a MRI scanner dedicated to emergency.

The primary endpoint is the proportion of patients with a diagnosis of stroke confirmed by imaging (MRI or Computed tomography (CT)) in the group "before implementation of the emergency MRI scanner" and the group "after implementation of the emergency MRI scanner".

The hypothesis is that the availability of a MRI scanner dedicated to emergency will improve the diagnosis of stroke in patients presenting with dizziness or diplopia, and will reduce Emergency Department stay, hospital stay and hospitalisation costs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-23
• Study Start: 2018-07-24
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-07
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• age over 18 years
• non opponent to participate
• dizziness or diplopia requiring brain imaging in order to eliminate stroke

Exclusion Criteria

• opponent to participate
• pregnant women
• recent cerebral trauma
• potentially eligible to thrombolysis
• impaired consciousness
• unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis is established on the positive signs of stroke highlighted on the CT scan or brain MRI according to the examination performed	18 months	Proportion of patients with a diagnosis of stroke confirmed by cerebral radiology (MRI or scan according to examination) in the pre- and post-MRI groups.

Secondary Outcome Measures

Name	Time	Method
Rate of new emergency department visits for neurological	the month following initial emergency care	Rate of new emergency department visits for neurological reasons in the month following initial emergency care
Evaluate the irradiation rate	18 months	Evaluate the irradiation rate related to the initial radiological examination performed during emergency care
Number of CT and brain MRI requested by the emergency physician in the before / after groups	18 months	Number of CT and brain MRI requested by the emergency physician in the before / after groups
Evaluate the usual management of vertigo and diplopia	18 months	Evaluate the usual management of vertigo and diplopia: number of CT and brain MRI requested by the emergency physician in the "before / after" groups; number of cerebral CT and MRI performed by the radiologist in the "before / after" groups
Evaluate the rate of new consultations in emergencies	18 months	Evaluate the rate of new consultations in emergencies for a neurological reason in the month following the initial care in emergencies, and the rate of new hospitalizations for the same reason
Evaluate the time of care	18 months	Evaluate the time of care: time of realization of the examination of radiology (scanner or brain MRI), delay of passage in emergencies

Trial Locations

Locations (1)

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France