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Clinical Trials/NCT05571254
NCT05571254
Completed
Not Applicable

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

NHS Lothian57 sites in 17 countries952 target enrollmentSeptember 12, 2022
ConditionsSyncope

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Syncope
Sponsor
NHS Lothian
Enrollment
952
Locations
57
Primary Endpoint
Referral source
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2022
End Date
December 2, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Referral source

Time Frame: Admission

Referral source

Participant gender

Time Frame: Admission

Participant gender

Participant age

Time Frame: Admission

Participant age

Mode of arrival

Time Frame: Admission

Mode of arrival

ESC high-risk 'past medical history' features

Time Frame: 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

Time Frame: Admission

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

Other medical comorbidities

Time Frame: Admission

Other medical comorbidities

Blood pressure (BP) on admission

Time Frame: Admission

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

ESC high risk 'physical examination' factors

Time Frame: Admission

ESC high risk 'physical examination' factors

Troponin levels

Time Frame: Admission

Troponin levels

D-dimer levels

Time Frame: Admission

D-dimer levels

Copeptin levels

Time Frame: Admission

Copeptin levels

Rockwood Clinical Frailty Scale score

Time Frame: 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

Time Frame: Admission

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

Lying/standing systolic BP difference on admission

Time Frame: Admission

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

Number of participants with abnormal Electrocardiogram (ECG) readings

Time Frame: Admission

Number of participants with abnormal ECG readings

Reason(s) for admission

Time Frame: Admission

Reason(s) for admission

Whether driving and occupation advice given

Time Frame: Admission

Whether driving and occupation advice given

Status at discharge from hospital

Time Frame: 30 days

Status at discharge from hospital

Natriuretic peptides levels

Time Frame: Admission

Natriuretic peptides levels

ED clinician diagnosis

Time Frame: Admission

ED clinician diagnosis - descriptive

Patient destination

Time Frame: 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

Time Frame: 30 days

Length of hospital stay in days

Hospital discharge diagnosis

Time Frame: 30 days

Hospital discharge diagnosis

Study Sites (57)

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