What Are the Main Themes Concerned by the Second-line SMU... | NCT06182514

Studies
What Are the Main Themes Concerned by the Second-line SMUR 67, Known as Reinforcements, in the Bas-Rhin Sector

NCT06182514

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 27, 2023Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Reasons for Emergency Calls

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jun 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Sep 6, 2022

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2023

Last Update Posted Date

Dec 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study the investigators wish to evaluate the possibility of anticipating the requests for SMUR reinforcement within the SAMU67.

The studied population concerns each patient having benefited from an SMUR at the time of his pre-hospital care. The investigators expect from this study an improvement of the assumption of responsibility of the patients in the future with optimization of the delay of sending of an SMUR when this one is necessary.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective description of the main reasons and themes of patient calls leading to the Emergency Medical Service being sent for reinforcement		Through study completion, an average of 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Adult patients having benefited from a pre-hospital SMUR over the period from 01/01/2020 to 14/07/2020.
No opposition from the patient or his parental authority to the re-use of his medical data for scientific research.

Exclusion criteria:

- Presence of opposition from the patient or his parental authority to the re-use of his medical data for scientific research purposes.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adult patients having benefited from a pre-hospital SMUR over the period from 01/01/2020 to 14/07/2020.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne WACH-HOFFMANN, MD	Contact	33 3 88 12 81 79		anne.hoffmann@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Urgences Médico-Chirurgicales Adules	Recruiting	Strasbourg		67091	France