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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03996733
Other study ID # JugulerUsgMaket
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date October 15, 2019

Study information

Verified date June 2021
Source Bozyaka Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date October 15, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Residents Exclusion Criteria: - Any experience on jugular venous catheterization - Experience of ultrasound guided interventions of any kind.

Study Design


Intervention

Other:
Lecture
Principal investigator of the study will lecture about the ultrasound guided jugular central venous catheterization according to latest guidelines.
Demo Video
Investigators of the study prepared a detailed demo-video showing insertion of a jugular central venous catheter with USG guidance. Principal investigator will vocalize the video in real-time.
UltrasoundImaging
Participants will exercise the proper visualisation of the right jugular vein at T6 level with USG guidance on a human subject.
ModelTraining
Participants will exercise the proper punction of juguler vein with USG guidance on the homemade jugular venous catheterization training model. Training model will include carotid artery, trachea and plaure in accordance with the real anatomy.

Locations

Country Name City State
Turkey Izmir Bozyaka Training and Research Hospital Karabaglar Izmir

Sponsors (1)

Lead Sponsor Collaborator
Zeki Tuncel Tekgul

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success Of The Catheterization Successful visualization of the jugular vein in long axis, successful puncture and draining the fluid in the jugular vein, successful visualization of insertion of the guide wire. All required. 5 minutes
Secondary Successful Visualization Successful visualization of the jugular vein in long axis. Yes or No. 5 minutes
Secondary Time Of The Successful Visualization Total time from puncture of the model's skin to the successful visualization of the jufular vein in long axis. 5 minutes
Secondary Puncture Count Total count of punctures on model skin. 5 minutes
Secondary Number Of Changes Of Needle Angle During The Procedure Retraction and orientation of the needle at different angles before the puncture of the jugular vein. 5 minutes
Secondary Puncture Time Total time from puncture of the model's skin to the successful puncture of the jugular vein. 5 minutes
Secondary Fail Of The Procedure Any of these four endpoints;
Puncture of pleura
Puncture of carotid artery
Puncture of the base(Too deep needle advancement)
Exceeding five minutes, before successful jugular venous catheterization
5 minutes
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