Using A Gelatin-Based Model In USG-Guided Jugular Venous Catheter Placement Training

The Effectiveness Of Using A Gelatin-Based Model In Ultrasonography Guided Jugular Central Venous Catheter Placement Training

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.

Study Overview

• Status: Completed
• Conditions: Education; Simulation Training; Vascular Access Devices; Ultrasonography, Interventional; Central Venous Catheters
• Intervention / Treatment: Other: Lecture; Other: Demo Video; Other: UltrasoundImaging; Other: ModelTraining

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir
    • Karabaglar, İzmir, Turkey, 35170
      • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Residents

Exclusion Criteria:

• Any experience on jugular venous catheterization
• Experience of ultrasound guided interventions of any kind.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GControl; Participants will attend the lecture for 30 minutes and watch a demo video showing the procedure. Later, they will practice ultrasound imaging of right jugular vein on a real human subject.	Other: Lecture; Principal investigator of the study will lecture about the ultrasound guided jugular central venous catheterization according to latest guidelines.; Other: 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.; Other: UltrasoundImaging; Participants will exercise the proper visualisation of the right jugular vein at T6 level with USG guidance on a human subject.
Experimental: GModel; Participants will attend the lecture for 30 minutes and watch a demo video showing the procedure. Later, they will practice ultrasound imaging of right jugular vein on a real human subject. Participants in this group will also practice jugular vein puncture on our homemade jugular central venous catheterization training model.	Other: Lecture; Principal investigator of the study will lecture about the ultrasound guided jugular central venous catheterization according to latest guidelines.; Other: 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.; Other: UltrasoundImaging; Participants will exercise the proper visualisation of the right jugular vein at T6 level with USG guidance on a human subject.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Visualization	Successful visualization of the jugular vein in long axis. Yes or No.	5 minutes
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
Puncture Count	Total count of punctures on model skin.	5 minutes
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
Puncture Time	Total time from puncture of the model's skin to the successful puncture of the jugular vein.	5 minutes
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

Collaborators and Investigators

• Sponsor: Zeki Tuncel Tekgul

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Training; Education; Model; Central Venous Catheterization; Ultrasound Guidance; Homemade
• Other Study ID Numbers: JugulerUsgMaket

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No