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临床试验/NCT05571254
NCT05571254已完成不适用

The Management of Transient Loss of Consciousness (TLOC) and Suspected Syncope in European Emergency Departments: a Prospective Cohort Study

NHS Lothian57 个研究点 分布在 17 个国家目标入组 952 人开始时间: 2022年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
NHS Lothian
入组人数
952
试验地点
57
主要终点
Referral source

研究概览

简要总结

Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.

详细描述

Syncope is a common ED problem. The three underlying causes are reflex (simple faint), orthostatic hypotension (blood pressure fall on standing) and cardiac disease (structural heart disease or cardiac dysrhythmia). Diagnosis is difficult and is not apparent in ~50% of patients after assessment. For the first time, European Society of Cardiology (ESC) guidelines incorporating ED management of patients presenting with TLOC, either undifferentiated or thought to be of syncopal origin, have been produced.

However, very little is currently known about the use of diagnostic algorithms and management of this patient group in EDs across Europe. As a result, the application of guidelines and the management of TLOC by European Society of Emergency Medicine (EUSEM) members in different countries and hospitals, cannot yet be recommended for use in settings other than those where they have been successfully validated.

This study aims to describe the prevalence, clinical presentation, current assessment, management strategies and ESC risk categories of patients presenting with TLOC (undifferentiated or thought to be of syncopal origin) to the ED, and will provide data to help identify the gaps in our knowledge and practice, and areas where further research and development work is required to fully implement European Society of Cardiology (ESC) guidelines within European EDs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult patients (≥18 years old) assessed in the ED with TLOC thought to be of syncopal origin.

排除标准

  • Inability to consent
  • Patient in custody or prison
  • Aged <18 years
  • TLOC thought to be due to neurological seizure (e.g., epilepsy/alcohol or drug withdrawal) or trauma

结局指标

主要结局

Referral source

时间窗: Admission

Referral source

Participant gender

时间窗: Admission

Participant gender

Participant age

时间窗: Admission

Participant age

Mode of arrival

时间窗: Admission

Mode of arrival

ESC high-risk 'past medical history' features

时间窗: Admission

Which European Society of Cardiology syncope high-risk 'past medical history' features are present

Presence of any European Society of Cardiology (ESC) syncope high-risk history features

时间窗: Admission

Which European Society of Cardiology syncope high-risk history features are present

Other medical comorbidities

时间窗: Admission

Other medical comorbidities

Blood pressure (BP) on admission

时间窗: Admission

First Blood pressure (BP) measure in the Emergency Department in mmHg

ESC high risk 'physical examination' factors

时间窗: Admission

ESC high risk 'physical examination' factors

Troponin levels

时间窗: Admission

Troponin levels

D-dimer levels

时间窗: Admission

D-dimer levels

Copeptin levels

时间窗: Admission

Copeptin levels

Rockwood Clinical Frailty Scale score

时间窗: Admission

Rockwood Clinical Frailty Scale is a well validated score ranging from 1 (Very Fit) to 9 (Terminally Ill) with defined descriptions for each category.

Pulse rate on admission

时间窗: Admission

First pulse rate measured in the Emergency Department in beats per minute

Lying/standing systolic BP difference on admission

时间窗: Admission

First lying/standing systolic BP difference measured in the Emergency Department in mmHg

Number of participants with abnormal Electrocardiogram (ECG) readings

时间窗: Admission

Number of participants with abnormal ECG readings

Reason(s) for admission

时间窗: Admission

Reason(s) for admission

Whether driving and occupation advice given

时间窗: Admission

Whether driving and occupation advice given

Status at discharge from hospital

时间窗: 30 days

Status at discharge from hospital

Natriuretic peptides levels

时间窗: Admission

Natriuretic peptides levels

ED clinician diagnosis

时间窗: Admission

ED clinician diagnosis - descriptive

Patient destination

时间窗: Admission

Descriptive options: Admitted to Observation/Clinical Decision Unit/Same Day Emergency Care unit/hospital floor with telemetry monitoring/hospital floor with no telemetry monitoring. Discharged to outpatient follow up/family doctor/General Practitioner care/home with no follow up

Length of hospital stay in days

时间窗: 30 days

Length of hospital stay in days

Hospital discharge diagnosis

时间窗: 30 days

Hospital discharge diagnosis

次要结局

未报告次要终点

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

研究点 (57)

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