Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department

October 7, 2022 updated by: University Hospital, Clermont-Ferrand

The goal of this observational study is to examine the clinical presentations, the diagnostic tests performed and the management of patients presenting with transient loss of consciousness (TLOC)

The main questions it aims to answer are:

  • prevalence of TLOC
  • prevalence of different diagnoses leading to TLOC Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients over the age of 18 presenting to the University Hospital of Clermont-Ferrand emergency department for transient loss of consciousness of syncopal or undifferentiated origin will be include. Their non-opposition will be sought.

Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file.

No visit is planned after the passage to the emergency room.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand
        • Principal Investigator:
          • Fares Moustafa, MD, PhD
        • Sub-Investigator:
          • Guillaume Muller

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

All adult patients presenting to the emergency room of the CHU de Clermont-Ferrand with a transient loss of consciousness of syncopal or undifferentiated origin will be included once the non-objection has been collected.

Description

Inclusion Criteria:

  • patients over 18 presenting to the Clermont-Ferrand University Hospital emergency department for transient loss of consciousness of syncopal or undifferentiated origin

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
prevalence of transient loss of consciousness in emergency department
Time Frame: through the study duration, an average of 6 months
Percentage of TLOC in emergency department
through the study duration, an average of 6 months
prevalence of different diagnoses leading to transient loss of consciousness
Time Frame: through the study duration, an average of 6 months
Percentage of different diagnoses leading to transient loss of consciousness
through the study duration, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of different clinical presentations of loss of consciousness
Time Frame: through the study duration, an average of 6 months
Percentage of different clinical presentations of loss of consciousness
through the study duration, an average of 6 months
Prevalence of the various diagnostic tests carried out and the treatment of patients presenting for transient loss of consciousness
Time Frame: through the study duration, an average of 6 months
Percentage of the various diagnostic tests carried out and the treatment of patients presenting for transient loss of consciousness
through the study duration, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Fares Moustafa, MD, PhD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Anticipated)

March 25, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EI22MG0908

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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