Pilot Study of a Nerve Block Simulator for the Training i... | NCT01982305

Studies
Pilot Study of a Nerve Block Simulator for the Training in Axillary Blocks

NCT01982305

Sponsor

Fundación Universitaria de Ciencias de la Salud

Status

Completed

Last Update Posted

Nov 13, 2013Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Arm Injuries

Interventions

Simulator
Cadaver

Countries

Not provided

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

Nov 2013

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

Aug 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Nov 6, 2013

First Submission Date that Met QC Criteria

Nov 12, 2013

First Posted Date

Nov 13, 2013Estimated

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

Nov 12, 2013

Last Update Posted Date

Nov 13, 2013Estimated

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

The purpose of this study is to determine whether an ultrasound-guided nerve block simulator is effective for the training of the axillary block technique.

Detailed Description

Ultrasound-guided nerve blocks are becoming the standard of care in patients requiring regional anesthesia. Cost-effective training is needed for the implementation of these techniques in the global anesthesia practice. Existing simulators are expensive and not available in low income countries. The investigators aimed to test an inexpensive simulator for the training in this technique.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simulator	Experimental	One training session with the simulator.	Procedure: Simulator
Cadaver	Active Comparator	One training session with a cadaver.	Procedure: Cadaver

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simulator	Procedure	Axillary nerve anatomy lecture plus training with the simulator.	Simulator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to locate axillary nerve in a cadaver		At the end of the procedure, expected average of 30 seconds

Secondary Outcomes

Measure	Description	Time Frame
Time to identify axillary nerve in a cadaver		During the procedure, expected average of 15 seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anesthesia residents

Exclusion Criteria:

Previous training in regional anesthesia techniques

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luis E Reyes, MD	Fundacion Universitaria de Ciencias de la Salud	Principal Investigator
Luis A Muñoz, MD	Fundacion Universitaria de Ciencias de la Salud	Principal Investigator

Locations

Not provided