Visibility - Classification of Sono-visibility of Anatomi... | NCT03231696

Studies
Visibility - Classification of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks

NCT03231696

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Dec 15, 2017Actual

Enrollment

1,200Actual

Phase

Not provided

Conditions

Anesthesia, Local
Anesthesia

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

Dec 2017

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 2012Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jul 25, 2017

First Submission Date that Met QC Criteria

Jul 25, 2017

First Posted Date

Jul 27, 2017Actual

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 14, 2017

Last Update Posted Date

Dec 15, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jurgen Birnbaum, Senior physician of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

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

We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.

Detailed Description

We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.

VIS(visibility) 1 easy identification and instant visualisation of all structures VIS 2 identification and visualisation of all structures after some corrections VIS 3 identification and visualisation of structures only unsure VIS 4 identification and visualisation of all structures impossible VIS 5 no structures seen. We amended a sub-project in which assessed the visibility in protective nerve stimulated nerve blocks in 46 patients.

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

1,200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients receiving Regional Anesthesia		All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visibility	The ultrasound visibility of the nerve scored by a 5-step scale.	During regional block (an average of 1 hour)

Secondary Outcomes

Measure	Description	Time Frame
Additional analgesia	The need and amount of additional analgetic drugs while the intervention.	During surgery (an average of 4 hours)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (study sample N=1200):

peripheral nerve block by ultrasound guidance
age ≥ 18 years

Exclusion Criteria:

contraindications for regional anesthesia

Inclusion Criteria (study sample as of amendment n=46):

peripheral nerve block by ultrasound guidance
age ≥ 18 years

Exclusion Criteria:

contraindications for regional anesthesia (study sample n=46)
using not the standard ultrasound machine
performing not a standard regional anesthesia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jürgen Birnbaum, MD	Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK		Berlin		10117	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