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

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05575934
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 21

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Syncope; Unconscious State

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 Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department
• Actual Study Start Date: Oct 3, 2022
• Anticipated Primary Completion Date: Mar 25, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Outcome Measures

Primary Outcome Measures

1. prevalence of transient loss of consciousness in emergency department [through the study duration, an average of 6 months]

   Percentage of TLOC in emergency department

2. prevalence of different diagnoses leading to transient loss of consciousness [through the study duration, an average of 6 months]

   Percentage of different diagnoses leading to transient loss of consciousness

Secondary Outcome Measures

1. prevalence of different clinical presentations of loss of consciousness [through the study duration, an average of 6 months]

   Percentage of different clinical presentations of loss of consciousness

2. Prevalence 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]

   Percentage of the various diagnostic tests carried out and the treatment of patients presenting for transient loss of consciousness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT05575934
• Other Study ID Numbers: EI22MG0908
• First Posted: Oct 12, 2022
• Last Update Posted: Oct 12, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Clermont-Ferrand: transient loss of consciousness; syncope; emergency department
• Additional relevant MeSH terms: Syncope; Unconsciousness; Emergencies

Study Results

No Results Posted as of Oct 12, 2022