The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Syncope

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (≥18 years old) assessed in the ED with TLOC thought to be of syncopal origin. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection|All patients will have a focussed Case Report Form completed collecting routine data describing the prevalence, clinical presentation, assessment, management and ESC risk category of patients, at the time or shortly after the patients ED attendance.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant age | Participant age | Admission | 
| Participant gender | Participant gender | Admission | 
| Mode of arrival | Mode of arrival | Admission | 
| Referral source | Referral source | Admission | 
| Presence of any European Society of Cardiology (ESC) syncope high-risk history features | Which European Society of Cardiology syncope high-risk history features are present | Admission | 
| ESC high-risk 'past medical history' features | Which European Society of Cardiology syncope high-risk 'past medical history' features are present | Admission | 
| Other medical comorbidities | Other medical comorbidities | Admission | 
| Rockwood Clinical Frailty Scale score | Rockwood Clinical Frailty Scale is a well validated score ranging from 1 (Very Fit) to 9 (Terminally Ill) with defined descriptions for each category. | Admission | 
| ESC high risk 'physical examination' factors | ESC high risk 'physical examination' factors | Admission | 
| Blood pressure (BP) on admission | First Blood pressure (BP) measure in the Emergency Department in mmHg | Admission | 
| Pulse rate on admission | First pulse rate measured in the Emergency Department in beats per minute | Admission | 
| Lying/standing systolic BP difference on admission | First lying/standing systolic BP difference measured in the Emergency Department in mmHg | Admission | 
| Number of participants with abnormal Electrocardiogram (ECG) readings | Number of participants with abnormal ECG readings | Admission | 
| Troponin levels | Troponin levels | Admission | 
| D-dimer levels | D-dimer levels | Admission | 
| Copeptin levels | Copeptin levels | Admission | 
| Natriuretic peptides levels | Natriuretic peptides levels | Admission | 
| ED clinician diagnosis | ED clinician diagnosis - descriptive | Admission | 
| Patient destination | 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 | Admission | 
| Reason(s) for admission | Reason(s) for admission | Admission | 
| Whether driving and occupation advice given | Whether driving and occupation advice given | Admission | 
| Status at discharge from hospital | Status at discharge from hospital | 30 days | 
| Length of hospital stay in days | Length of hospital stay in days | 30 days | 
| Hospital discharge diagnosis | Hospital discharge diagnosis | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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syncope, transient loss of consciousness, emergency department