Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT03996733
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2019-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using A Gelatin-Based Model In USG-Guided Jugular Venous Catheter Placement Training
Sponsor:
Zeki Tuncel Tekgul
Organization:
Study Overview
Official Title:
The Effectiveness Of Using A Gelatin-Based Model In Ultrasonography Guided Jugular Central Venous Catheter Placement Training
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An education model with a homemade jugular venous catheterization model will be compared to the conventional training model for ultrasound-guided central jugular line catheterization.
The study will include 60 residents to be divided into two groups with stratified random sampling.
Training session for the control group (Group 2) will include a lecture about the subject, a demo video presentation, and practice of visualization of right jugular vein on a real human subject.
Training session for the model group (Group 1) will include the same as GControl with the addition of the puncture practice on the homemade jugular venous catheterization model(HJVCM) with ultrasound guidance.
Both groups will be tested with another HJVCM individually and the results of the success and fail parameters will be compared.
The study will include 60 residents to be divided into two groups with stratified random sampling.
Training session for the control group (Group 2) will include a lecture about the subject, a demo video presentation, and practice of visualization of right jugular vein on a real human subject.
Training session for the model group (Group 1) will include the same as GControl with the addition of the puncture practice on the homemade jugular venous catheterization model(HJVCM) with ultrasound guidance.
Both groups will be tested with another HJVCM individually and the results of the success and fail parameters will be compared.
Detailed Description:
According to the latest guidelines, ultrasound guidance has become the golden standard in Jugular Central Venous Catheter applications. This reveals the necessity of theoretical and practical training on USG for jugular central venous catheter training. Models for jugular venous catheterization training are few in number and also expensive. Thus, the investigators built an Homemade Jugular Venous Catheterization Model which meant to be cheap and easy to make and transport. With this study, the investigators will test whether this model will provide any benefit to the success of the training on USG Guided Jugular Venous Catheterization.
Two different training sessions are planned as one will include the training model and the other will not. The study will be conducted with resident physicians without any experience on jugular venous catheterization or ultrasound-guided interventions of any kind. Participants will be divided into two groups with stratified random sampling (According to specialties and years of residency) and the both will attend to a 30 minutes lecture on jugular venous catheterization with US guidance and basic ultrasound principles including a demo video illustrating the procedure. Later, the participants will practice ultrasound imaging of right jugular vein on a real human subject. The model training group will be named Group 1 and control group will be named Group 2. Group 1 will also practice jugular vein puncture on the training model. After training sessions, each participant will be tested with a different model placed in a manikin. The assessment session will include successful visualization of the jugular vein, puncture of the jugular vein, and insertion of the guide wire. Evaluation of the success and fail parameters (explained in outcome parameters) will be monitored by four educated supervisors. The sessions for both of the groups are planned to take 120 minutes in total and the assessment will be limited to five minutes individually.
Two different training sessions are planned as one will include the training model and the other will not. The study will be conducted with resident physicians without any experience on jugular venous catheterization or ultrasound-guided interventions of any kind. Participants will be divided into two groups with stratified random sampling (According to specialties and years of residency) and the both will attend to a 30 minutes lecture on jugular venous catheterization with US guidance and basic ultrasound principles including a demo video illustrating the procedure. Later, the participants will practice ultrasound imaging of right jugular vein on a real human subject. The model training group will be named Group 1 and control group will be named Group 2. Group 1 will also practice jugular vein puncture on the training model. After training sessions, each participant will be tested with a different model placed in a manikin. The assessment session will include successful visualization of the jugular vein, puncture of the jugular vein, and insertion of the guide wire. Evaluation of the success and fail parameters (explained in outcome parameters) will be monitored by four educated supervisors. The sessions for both of the groups are planned to take 120 minutes in total and the assessment will be limited to five minutes individually.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: