No registrations found.
Source
Brief title
Health condition
Acute vestibular syndrome. Vertebrobasilar/cerebellar stroke. Peripheral vestibular syndrome.
Sponsors and support
Co-financing St. Jacobusstichting.
In-kind contribution Neurobit Technologies.
Intervention
No registrations found.
Outcome measures
Primary outcome
Final diagnosis (stroke or peripheral) 3 months after inclusion.
Secondary outcome
- Healthcare costs (costs related to days of admission, costs of MRI/CT scans).
- Resource use measurement during 3 months follow-up.
- Quality Adjusted Life Years during 3 months follow-up.
- Sensitivity/specificity of MRI DWI of the brain within 24 hours.
- Sensitivity/specificity of MRI DWI of the brain after 72 hours.
- Sensitivity/specificity of the “clinical gestalt” of the doctor.
- Differences in sensitivity/specificity of the HINTS+ examination between neurologists/neurology residents and ED physicians/ED residents.
- Incidence of acute onset, continuous dizziness (and proportion of stroke) in Dutch ED population.
Background summary
This study is a prospective, multicenter, cohort investigation to determine the optimal diagnostic work-up for patients with isolated, acute onset, continuous dizziness presenting to emergency departments. Patients 18 years and older presenting to the ED with acute onset, continuous dizziness and without neurological deficits or clear other diagnosis will be included in this study. All patients will undergo HINTS+ test, standarized questionnaires and MRI brain within 24 hours A selected group of patients will undergo a MRI brain after 72 hours as well. Follow-up time is 3 months, with the primary study parameter being ‘final’ diagnosis after 3 months. We will determine the sensitivity, specificity, positive predictive and negative predictive value of both the HINTS+ test as MRI brain within 24 and after 72 hours. Furthermore we will perform an economic evaluation of the HINTS+ test using a budget impact analysis and cost utility analysis. Eventually study data will be used to draft a national guideline and decision model for the diagnostics and treatment of isolated, acute onset, continuous dizziness.
Study objective
We hypothesize that the HINTS+ test is more reliable than early MRI imaging in patients with acute onset continuous dizziness.
As a result it is hypothesized that HINTS+ clinical examination leads to lower costs and an improvement in Quality of Life.
Study design
Day 0, Day 1, Day 3, Discharge, Follow-up after 3 months.
Intervention
Not applicable.
Inclusion criteria
- Acute onset, continuous dizziness, still present at arrival on the ED;
- Presentation within 24 hours after onset of dizziness;
- Age 18 years or older.
Exclusion criteria
- Clear signs of benign paroxysmal positional vertigo (BPPV) (i.e. acute onset, continuous dizziness successfully treated by canalith repositioning);
- A history of recognizable recurrent vertigo or acute onset, continuous dizziness compatible with Meniere’s disease or vestibular migraine;
- Deficits upon neurological examination other than a nystagmus (i.e. ataxia (gait imbalance is allowed), dysarthria, spontaneous skew deviation, gaze palsy or lowered state of consciousness (i.e. EMV <14));
- Pregnancy at the time of inclusion;
- Known contra-indication for MRI (e.g. claustrofobia, non MRI-compatible pacemaker or ICD);
- Clear medical condition other than stroke (central) or non-stroke (peripheral) vestibular disorder that explains acute onset, continuous dizziness. Examples are hypotension, sepsis, medication related;
- Previous inclusion in study;
- No informed consent;
- Unable to undergo follow up (e.g. life expectancy <3 months, severe cognitive impairment, no permanent residence in the Netherlands);
- Insufficient command of the Dutch language.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9197 |
Other | METC LDD (Leiden Den Haag Delft) : P21.029 METC LDD |