Study on Application of Simulated Training in Ultrasound... | NCT04388423

Studies
Study on Application of Simulated Training in Ultrasound Guided Transversus Abdominis Plane Block

NCT04388423

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Jul 14, 2020Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Transversus Abdominis Plane Block
Simulation Training
Learning Curve

Interventions

simulated puncture training
traditional bedside teaching

Countries

China

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jan 1, 2021Estimated

First Submitted Date

May 12, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 14, 2020Actual

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

Jul 13, 2020

Last Update Posted Date

Jul 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

With the development of society and the enhancement of people's awareness of law and self-protection, it is necessary to use simulation technology to create a simulated human and clinical environment to replace the traditional teaching of clinical operation on real patients. So simulation teaching is more and more important in medical education. However, simulation teaching is in the ascendant in China, especially in the ultrasound-guided nerve block, limited by the lack of full simulation of puncture model, the simulation training of ultrasound-guided nerve block is not carried out much. Therefore, this study uses simulation training to carry out ultrasound-guided horizontal abdominal muscle block teaching, in order to explore an effective way of ultrasound-guided nerve block teaching.

Detailed Description

Not provided

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

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group S	Experimental		Other: simulated puncture training
Group C	Experimental		Other: traditional bedside teaching

Interventions

Name	Type	Description	Arm Group Labels	Other Names
simulated puncture training	Other	The residents are trained of simulated puncture : 1.the location puncture; 2. finding fixed-point needle on the model for 5 times, each time for 30 minutes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The time taken to complete the blocking operation	After finishing the disinfection sheet, the operator began to perform unilateral transversal muscle planar ultrasound scanning, positioning and puncture until the end of injection.	procedure/surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-70 years old; ASA 1 ~ 2; patients under non-transvaginal gynecologic surgery, rectal surgery or descending colon surgery

Exclusion Criteria:

Patients with communication disorder Central or peripheral nervous system diseases. Liver and kidney functions seriously damaged Coagulation function abnormality and local anesthetic allergy history Patients with serious heart disease, hypertension and diabetes. Patients who have used analgesic drugs or drugs that may affect cardiovascular function within 24 hours before operation.

Patients with infection at the puncture site.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital		Beijing	Haidian	100853	China