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A Homemade Model for US Guided Central Jugular Line Catheterization Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996733
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Zeki Tuncel Tekgul, Bozyaka Training and Research Hospital

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(GControl) 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(GModel) 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.


Condition or disease Intervention/treatment Phase
Central Venous Catheters Vascular Access Devices Education Simulation Training Ultrasonography, Interventional Other: Lecture Other: Demo Video Other: UltrasoundImaging Other: ModelTraining Not Applicable

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 our own Homemade Jugular Venous Catheterization Model(HJVCM) 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 education model(HJVCM) and the other will not. The study will be conducted with resident doctors 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 departments and years of residents) and the both will attend to a lecture on jugular venous catheterization with US guidance and basic ultrasound principles for 20 minutes. Then, a demo video illustrating the procedure will be displayed. Later, the participants will practice ultrasound imaging of right jugular vein on a real human subject. Control group will be named GControl and test group will be named GModel. GModel will also practice jugular vein puncture on the HJVCM. After training sessions, each participant will be tested with a different HJVCM placed in a mannequin. The test 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 90 minutes and the test will be limited to five minutes individually.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Efficacy of Using Homemade Model in Ultrasound Guided Jugular Central Venous Catheterization Training
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: GControl
Participants will attend the lecture for 20 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 20 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.





Primary Outcome Measures :
  1. Success Of The Catheterization [ Time Frame: 5 minutes ]
    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.


Secondary Outcome Measures :
  1. Successful Visualization [ Time Frame: 5 minutes ]
    Successful visualization of the jugular vein in long axis. Yes or No.

  2. Time Of The Successful Visualization [ Time Frame: 5 minutes ]
    Total time from puncture of the model's skin to the successful visualization of the jufular vein in long axis.

  3. Puncture Count [ Time Frame: 5 minutes ]
    Total count of punctures on model skin.

  4. Number Of Changes Of Needle Angle During The Procedure [ Time Frame: 5 minutes ]
    Retraction and orientation of the needle at different angles before the puncture of the jugular vein.

  5. Puncture Time [ Time Frame: 5 minutes ]
    Total time from puncture of the model's skin to the successful puncture of the jugular vein.

  6. Fail Of The Procedure [ Time Frame: 5 minutes ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Residents

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996733


Contacts
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Contact: Zeki Tuncel Tekgul, Assoc. Prof. +902322505050 ext 5003 zekittekgul@yahoo.com
Contact: Mehmet Ugur Bilgin +905545118874 ugurbilginege@gmail.com

Sponsors and Collaborators
Zeki Tuncel Tekgul
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Responsible Party: Zeki Tuncel Tekgul, Assoc. Prof. Dr, Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03996733    
Other Study ID Numbers: JugulerUsgMaket
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zeki Tuncel Tekgul, Bozyaka Training and Research Hospital:
Training
Education
Homemade
Model
Central Venous Catheterization
Ultrasound Guidance