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临床试验/NCT05062915
NCT05062915已完成不适用

Diagnostic Work up and Management of Acute Onset Vertigo

Esbjerg Hospital - University Hospital of Southern Denmark2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Number of undiagnosed and misdiagnosed cases

研究概览

简要总结

Incidence: Dizziness or vertigo is a very prevalent complaint in the general population, and a common reason for seeking medical attention. In Denmark, 20-30 % have experienced dizziness/vertigo to a degree that has led to disability, sick leave, or medical contact(1). In the United States, dizziness is estimated to account for partly 2.6-4.4 million visits to emergency departments (EDs) each year, partly 4 % of main symptoms in patients admitted to EDs (2). In Germany, the estimated prevalence of dizziness is 20-30 % with an annual incidence about 11 % (3).

Terminology and definition: Dizziness or vertigo is not a disease itself but rather a symptom of various underlying disorders. Thus, vestibular, neurological, cardiovascular, metabolic, and psychiatric diseases may be associated with dizziness/vertigo as well as medical side effects. Patients (and professionals) often use the two terms dizziness and vertigo synonymously, which may cause some confusion in the choice of diagnostics. Vertigo is characteristic for vestibular disorders and is defined as sensation of self-motion when no self-motion occurs, or sensation of distorted self-motion during an otherwise normal head movement, whereas dizziness is a feeling of more general unsteadiness.

  1. Is implementation of HINTS and v-HIT in an ED able to reduce the number of undiagnosed and misdiagnosed cases of acute onset vertigo as well as diagnostic delay ?
  2. What are the effects of immediate and systematic balance training in case of acute vestibular diseases ?
  3. What is the cost-effectiveness of implementation of HINTS and v-HIT as up front diagnostics, and systematic balance training in patients with acute vestibular diseases ?

详细描述

Phd thesis will be done including these 3 parts. STUDY 1 Effects of implementation of HINTS and v-HIT in an emergency department HYPOTHESIS Implementation of HINTS and v-HIT in the acute diagnostic workup for patients presenting with acute onset dizziness/vertigo at the ED, Hospital of South West Jutland (SVS), Denmark, along with the routine triage and acute MRI of the brain can reduce the number of un-/misdiagnosed cases to almost zero at the time of discharge from hospital.

HINTS and V-hit can be performed by a nurse at the ED with a high level of accuracy.

AIMS To investigate the effects of implementing nurse-performed v-HIT and HINTS in patients presenting with acute onset dizziness/vertigo in the ED.

DESIGN A prospective cohort of unselected patients with acute onset dizziness/vertigo is compared to a baseline (historical) cohort.

POPULATIONS

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

盲法说明

Bloc randomisation done by a physical therapist: only for the part of the study with vestibular rehabilitation

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria: all consecutive adult patients (18 years and older) admitted to the ED with acute onset vertigo/dizziness (AVS) as the primary complaint.

排除标准

  • patients with known vestibular disease, vestibular symptoms lasting more than two days.

研究组 & 干预措施

Baseline population

No Intervention

Historic cohorte for comparisson in study 1. Baseline population 1 all patients with AVS. Baseline 2 population part of baseline 1 but with peripheral cause of AVS. Are offered late onset vestibular rehabilitaion if they have balance deficit.

Study population

Active Comparator

The study population is divided into 2 groups, based on the findings in the clinical investigation.

study population 1: all patients with acute Vestibular syndrome (AVS) Study population 2: all patients from study group 1, with vestibular/peripheral cause of AVS. They are offered early onset rehabilitation.

Arm 1 and 2 are compared for cost-effectiveness and compared to the costs of the diagnosis.

干预措施: HINTS (Diagnostic Test)

结局指标

主要结局

Number of undiagnosed and misdiagnosed cases

时间窗: 1,5 years

cases in the two populations is calculated at the time of discharge from ED. Definitions: Undiagnosed: cases without specific ICD10 code explaining acute dizziness/vertigo. Misdiagnosed: cases in which the chart review (baseline population) reveals obviously wrong ICD10 codes/post-hospital examinations reveal the specific cause of dizziness/vertigo; or ENT-examination within 24 hours changes the primary diagnosis (study population 1).

Cost-effectiveness of implementing up front diagnostics and balance training in patients with acute onset dizziness

时间窗: 1 years

To examine the cost-effectiveness of up front diagnostics and balance training in prospective cohorts of patients with acute onset dizziness compared to a historical control group. A cost-effectiveness analysis will be conducted. Costing: The costs of up front diagnosis and balance training will be estimated using micro-costing. Use of primary healthcare services will be extracted and valued from the Danish National Health Service Register for Primary Care (NHSR). Use of secondary healthcare services will be extracted from the National Patient Registry (NPR). Productivity loss will be extracted from the Danish Register for Evaluation of Marginalization (DREAM) and valued by age- and gender-matched average gross salaries from Statistics Denmark (www.dst.dk).

Percentage of patients undergoing HINTS in the baseline population

时间窗: 1 year

Percentage of patients undergoing HINTS in the baseline population, and percentage of patients undergoing HINTS and v-HIT in study population 1.

Percentage of patients with complete recovery

时间窗: 1,5 years

Percentage of patients with complete recovery one year after the acute attack defined as resumption of all daily day activities. Degree of vestibular deficit scored by the DHI questionnaire. Vestibular status in baseline population 2 (12 months after admission) is compared to vestibular status at one year follow up in study population 2 in terms of HINTS, v-HIT, VNG, posturography.

次要结局

  • Time to correct diagnosis(1,5 years)
  • Vestibular status in study population 2 at admission and at one year follow up are compared. Progression through the balance training program is evaluated by change in vestibular status(2,5 years)

研究者

发起方
Esbjerg Hospital - University Hospital of Southern Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helle Elisabeth Agger-Nielsen

Doctor

Esbjerg Hospital - University Hospital of Southern Denmark

研究点 (2)

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