INVITE Study: Invasive Instrumentation in Trauma Patients... | NCT02666677

Studies
INVITE Study: Invasive Instrumentation in Trauma Patients in the Shock Room

NCT02666677

Sponsor

Universitätsklinikum Köln

Status

Completed

Last Update Posted

Apr 4, 2019Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Multiple Trauma

Interventions

Not provided

Countries

Germany

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Jan 25, 2016

First Submission Date that Met QC Criteria

Jan 27, 2016

First Posted Date

Jan 28, 2016Estimated

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

Apr 3, 2019

Last Update Posted Date

Apr 4, 2019Actual

Name	Class
Universitätsklinikum Leipzig	OTHER
Wuerzburg University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study is an online survey asking for invasive instrumention in trauma patients of an emergency department

Detailed Description

The INVITE study is an online survey for medical doctors asking for invasive instrumention (e.g., arterial line, entral venous line, etc.) in trauma patients of an emergency department

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

1,500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
"Insertion of central venous catheter " survey		Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with multiple trauma
treated in the emrgency department

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Traumatized patiennts in the emergency department

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen Hinkelbein, MD	UK Köln	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Cologne		Cologne	North Rhine-Westphalia	50937	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided