Transfer of Standard Operating Procedures in Anesthesiology | NCT04800796

Studies
Transfer of Standard Operating Procedures in Anesthesiology

NCT04800796

Sponsor

Johannes Gutenberg University Mainz

Status

Completed

Last Update Posted

Mar 16, 2021Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Patient Safety

Interventions

Audiovisual

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

Mar 2021

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

Mar 1, 2021Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Mar 7, 2021Actual

First Submitted Date

Mar 9, 2021

First Submission Date that Met QC Criteria

Mar 15, 2021

First Posted Date

Mar 16, 2021Actual

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

Mar 15, 2021

Last Update Posted Date

Mar 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marc Kriege, MD, Principal Investigator, Johannes Gutenberg University MainzPrincipal Investigator

Lead Sponsor

Johannes Gutenberg University MainzOTHER

Collaborators

Not provided

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

Patients safety and high Quality Performance built up the centre of anesthesiology. Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or complications.

Detailed Description

The Primary endpoint is the comparison of a Intervention Group with audiovisually blended learning concept and a Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group		Intervention Group with audiovisually blended learning concept	Other: Audiovisual
Standard group		Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Audiovisual	Other	Receive blended learning before and reading the Standard operating procedure	Intervention Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of SOP deviations	SOP deviations during scenario training	12 minutes after start scenario

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

anesthesia residents
anesthesia consultants

Exclusion:

nurses
students

Accepts Healthy Volunteers

Yes

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

anesthesia physicians who participating in a Scenario training

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Kriege, MD, PhD	University JG, Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University		Mainz	Rhineland-Palatinate	D55131	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

Intervention Browse Module

MeSH Terms

ID	Term
D001296	Audiovisual Aids

Ancestor Terms

ID	Term
D018961	Educational Technology
D013672	Technology
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided