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

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

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.

Study Overview

• Status: Completed
• Conditions: Syncope
• Intervention / Treatment: Other: Data collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 952

Contacts and Locations

Study Locations

• Albania
  • Durres, Albania
    • Regional Hospital Durres
  • Elbasan, Albania
    • Regional Hospital Centre "Xh. Kongoli" Elbasan
  • Sarande, Albania
    • Spitali "Petro Nako" Sarandra
  • Shkodra, Albania
    • Regional Hospital Shkoder
  • Tirana, Albania
    • University Hospital Centre "Mother Theresa" Tirana
• Austria
  • Vienna, Austria
    • Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken
  • Vienna, Austria
    • Klinik Donaustadt
• Belgium
  • Brugge, Belgium
    • AZ Sint Jan Brugge
  • Eeklo, Belgium
    • AZ Alma Eeklo
  • Ghent, Belgium
    • Ghent University Hospital
  • Lier, Belgium
    • Heilig Hartziekenhuis Lier
• Czechia
  • Králová, Czechia
    • University Hospital Hradec Kralove
  • Praha, Czechia
    • University Hospital Kralovske Vinohrady
• Denmark
  • Herning, Denmark
    • Regionshospitalet Gødstrup
  • Hillerød, Denmark
    • Nordsjællands Hospital
  • Randers, Denmark
    • Regionshospitalet Randers
  • Roskilde, Denmark
    • Sjællands Universitetshospital
  • Vildbjerg, Denmark
    • Regionshospitalet Midt
• Finland
  • Helsinki, Finland
    • Kanta-Häme Central Hospital
• France
  • Besançon, France
    • CHU Besançon
  • Caen, France
    • CHU Caen
  • Clermont-Ferrand, France
    • CHU Clermond-Ferrand
  • Lyon, France
    • Medipole
  • Tours, France
    • CHU Tours
• Greece
  • Athens, Greece
    • University General Hospital Attikon
  • Heraklion, Greece
    • General Hospital Venizeleio
  • Thessaloníki, Greece
    • AHEPA Univesrity General Hospital of Thessaloniki
• Hungary
  • Budapest, Hungary
    • Semmelweis University Department of Emergency Medicine
• Italy
  • Bologna, Italy
    • ED Azienda Ospedaliera Universitaria di Bologna (Sant'Orsola Hospital)
  • Catania, Italy
    • ED Azienda Ospedaliera-universitaria di Catania (San Marco Hospital)
  • Firenze, Italy
    • ED Azienda USL Toscana Centro, Firenze (San Giovanni di Dio Hospital)
  • Perugia, Italy
    • Azienda Ospedaliera di Perugia (Santa Maria Della Misericordia Hospital)
  • Verona, Italy
    • ED Azienda Ospedaliera-Universitaria integrata (Borgo Trento Hospital)
• Malta
  • Birkirkara, Malta
    • Mater dei hospital
  • Victoria, Malta
    • Gozo General Hospital
• Norway
  • Trondheim, Norway
    • St. Olav's University Hospital
• Poland
  • Wrocław, Poland
    • Wroclaw University Hospital
• Romania
  • Cluj-Napoca, Romania
    • Cluj Napoca County Emergency Clinical Hospital
  • Iaşi, Romania
    • Saint Spiridon County Hospital
• Serbia
  • Belgrad, Serbia
    • Emergency Center Belgrade, Clinical Centre Belgade
  • Niš, Serbia
    • Clinical Centre of Nis
  • Zaječar, Serbia
    • Emergency Department Zaječar, Health Center Zaječar
• Spain
  • Alicante, Spain
    • Hospital Dr. Balmis
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
  • Barcelona, Spain
    • Hospital Clinic Barcelona
  • Barcelona, Spain
    • Hospital de Terrassa
  • Barcelona, Spain
    • Hospital Universitari de Vic
• Turkey
  • Ankara, Turkey
    • Gazi University Medical Faculty Department of Emergency Medicine
  • Ankara, Turkey
    • Medical Science University Ankara Education and Research Hospital Department of Emergency Medicine
  • Karaman, Turkey
    • Karamanoglu Mehmetbey University Karaman Education and Research Hospital Department of Emergency Medicine
  • Konya, Turkey
    • Necmettin Erbakan University Medical Faculty Department of Emergency Medicine
  • Şanlıurfa, Turkey
    • Medical Science University Sanliurfa Mehmet Akif Inan Education and Research Hospital Department of Emergency Medicine
• United Kingdom
  • Coventry, United Kingdom
    • University Hospital Coventry & Warwickshire
  • Kirkcaldy, United Kingdom
    • Victoria Hospital
  • Livingston, United Kingdom
    • St Johns Hospital, Livingston
  • Preston, United Kingdom
    • Royal Preston Hospital
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH16 4SA
      • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults 18 years of age and older presenting to the ED over a two-week period with TLOC, either undifferentiated or thought to be of syncopal origin.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NHS Lothian
• Investigators: Study Chair: Matt Reed, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: syncope; emergency department; transient loss of consciousness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Consciousness Disorders; Emergencies; Syncope; Unconsciousness
• Other Study ID Numbers: AC22033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No