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

Completed

• 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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-12
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Primary Completion: 2022-12-02
• Study Completion: 2022-12-02
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 952

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant gender	Admission	Participant gender
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
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
Referral source	Admission	Referral source

Trial Locations

Locations (57)

Regional Hospital Durres; 🇦🇱 Durres, Albania

Regional Hospital Centre "Xh. Kongoli" Elbasan; 🇦🇱 Elbasan, Albania

Spitali "Petro Nako" Sarandra; 🇦🇱 Sarande, Albania

Regional Hospital Shkoder; 🇦🇱 Shkodra, Albania

University Hospital Centre "Mother Theresa" Tirana; 🇦🇱 Tirana, Albania

Allgemeines Krankenhaus der Stadt Wien/ Universitätskliniken; 🇦🇹 Vienna, Austria

Klinik Donaustadt; 🇦🇹 Vienna, Austria

AZ Sint Jan Brugge; 🇧🇪 Brugge, Belgium

AZ Alma Eeklo; 🇧🇪 Eeklo, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium

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