The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments
- Conditions
- Syncope
- Registration Number
- NCT05571254
- Lead Sponsor
- NHS Lothian
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 952
- Adult patients (≥18 years old) assessed in the ED with TLOC thought to be of syncopal origin.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rockwood Clinical Frailty Scale score 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 Admission First pulse rate measured in the Emergency Department in beats per minute
Lying/standing systolic BP difference on admission Admission First lying/standing systolic BP difference measured in the Emergency Department in mmHg
Number of participants with abnormal Electrocardiogram (ECG) readings Admission Number of participants with abnormal ECG readings
Reason(s) for admission Admission Reason(s) for admission
Whether driving and occupation advice given Admission Whether driving and occupation advice given
Status at discharge from hospital 30 days Status at discharge from hospital
Natriuretic peptides levels Admission Natriuretic peptides levels
ED clinician diagnosis Admission ED clinician diagnosis - descriptive
Patient destination 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 30 days Length of hospital stay in days
Hospital discharge diagnosis 30 days Hospital discharge diagnosis
Participant gender Admission Participant gender
Referral source Admission Referral source
Participant age Admission Participant age
Presence of any European Society of Cardiology (ESC) syncope high-risk history features Admission Which European Society of Cardiology syncope high-risk history features are present
Other medical comorbidities Admission Other medical comorbidities
Blood pressure (BP) on admission Admission First Blood pressure (BP) measure in the Emergency Department in mmHg
Mode of arrival Admission Mode of arrival
ESC high-risk 'past medical history' features Admission Which European Society of Cardiology syncope high-risk 'past medical history' features are present
ESC high risk 'physical examination' factors Admission ESC high risk 'physical examination' factors
Troponin levels Admission Troponin levels
D-dimer levels Admission D-dimer levels
Copeptin levels Admission Copeptin levels
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
Regional Hospital Shkoder
🇦🇱Shkodra, Albania
AZ Sint Jan Brugge
🇧🇪Brugge, Belgium
Ghent University Hospital
🇧🇪Ghent, Belgium
AZ Alma Eeklo
🇧🇪Eeklo, Belgium
Heilig Hartziekenhuis Lier
🇧🇪Lier, Belgium
University Hospital Hradec Králové
🇨🇿Králová, Czechia
University Hospital Královské Vinohrady
🇨🇿Praha, Czechia
CHU Besançon
🇫🇷Besançon, France
CHU Clermond-Ferrand
🇫🇷Clermont-Ferrand, France
Medipole
🇫🇷Lyon, France
University General Hospital ATTIKON
🇬🇷Athens, Greece
General Hospital Venizeleio
🇬🇷Heraklion, Greece
ED Azienda USL Toscana Centro, Firenze (San Giovanni di Dio Hospital)
🇮🇹Firenze, Italy
AHEPA Univesrity General Hospital of Thessaloniki
🇬🇷Thessaloníki, Greece
ED Azienda Ospedaliera Universitaria di Bologna (Sant'Orsola Hospital)
🇮🇹Bologna, Italy
ED Azienda Ospedaliera-universitaria di Catania (San Marco Hospital)
🇮🇹Catania, Italy
Semmelweis University Department of Emergency Medicine
🇭🇺Budapest, Hungary
Mater Dei Hospital
🇲🇹Birkirkara, Malta
ED Azienda Ospedaliera-Universitaria integrata (Borgo Trento Hospital)
🇮🇹Verona, Italy
Azienda Ospedaliera di Perugia (Santa Maria Della Misericordia Hospital)
🇮🇹Perugia, Italy
Gozo General Hospital
🇲🇹Victoria, Malta
St. Olav's University Hospital
🇳🇴Trondheim, Norway
Wroclaw University Hospital
🇵🇱Wrocław, Poland
Emergency Center Belgrade, Clinical Centre Belgade
🇷🇸Belgrad, Serbia
Emergency Department Zaječar, Health Center Zaječar
🇷🇸Zaječar, Serbia
Hospital Universitari de Vic
🇪🇸Barcelona, Spain
Hospital de Terrassa
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital clinic Barcelona
🇪🇸Barcelona, Spain
Hospital Dr. Balmis
🇪🇸Alicante, Spain
Gazi University Medical Faculty Department of Emergency Medicine
🇹🇷Ankara, Turkey
Medical Science University Ankara Education and Research Hospital Department of Emergency Medicine
🇹🇷Ankara, Turkey
Karamanoglu Mehmetbey University Karaman Education and Research Hospital Department of Emergency Medicine
🇹🇷Karaman, Turkey
Necmettin Erbakan University Medical Faculty Department of Emergency Medicine
🇹🇷Konya, Turkey
Medical Science University Sanliurfa Mehmet Akif Inan Education and Research Hospital Department of Emergency Medicine
🇹🇷Şanlıurfa, Turkey
University Hospital Coventry & Warwickshire
🇬🇧Coventry, United Kingdom
Victoria Hospital
🇬🇧Kirkcaldy, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, Midlothian, United Kingdom
St Johns Hospital, Livingston
🇬🇧Livingston, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
University Hospital Centre "Mother Theresa" Tirana
🇦🇱Tirana, Albania
Saint Spiridon County Hospital
🇷🇴Iaşi, Romania
Spitali "Petro Nako" Sarandra
🇦🇱Sarande, Albania
Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken
🇦🇹Vienna, Austria
Klinik Donaustadt
🇦🇹Vienna, Austria
Regional Hospital Durres
🇦🇱Durres, Albania
Kanta-Häme Central Hospital
🇫🇮Helsinki, Finland
Clinical Centre of Niš
🇷🇸Niš, Serbia
Cluj Napoca County Emergency Clinical Hospital
🇷🇴Cluj-Napoca, Romania
Regional Hospital Centre "Xh. Kongoli" Elbasan
🇦🇱Elbasan, Albania
CHU Caen
🇫🇷Caen, France
Regionshospitalet Gødstrup
🇩🇰Herning, Denmark
Nordsjællands Hospital
🇩🇰Hillerød, Denmark
Regionshospitalet Randers
🇩🇰Randers, Denmark
Sjællands Universitetshospital
🇩🇰Roskilde, Denmark
Regionshospitalet Midt
🇩🇰Vildbjerg, Denmark
CHU Tours
🇫🇷Tours, France