NCT03996733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

29 days

First QC Date

June 19, 2019

Last Update Submit

June 2, 2021

Conditions

Keywords

TrainingEducationHomemadeModelCentral Venous CatheterizationUltrasound Guidance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Successful Visualization

    5 minutes

  • Time Of The Successful Visualization

    5 minutes

  • Puncture Count

    5 minutes

  • Number Of Changes Of Needle Angle During The Procedure

    5 minutes

  • Puncture Time

    5 minutes

  • +1 more secondary outcomes

Study Arms (2)

GControl

ACTIVE COMPARATOR

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: LectureOther: Demo VideoOther: UltrasoundImaging

GModel

EXPERIMENTAL

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: LectureOther: Demo VideoOther: UltrasoundImagingOther: ModelTraining

Interventions

LectureOTHER

Principal investigator of the study will lecture about the ultrasound guided jugular central venous catheterization according to latest guidelines.

GControlGModel

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.

GControlGModel

Participants will exercise the proper visualisation of the right jugular vein at T6 level with USG guidance on a human subject.

GControlGModel

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.

GModel

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Karabağlar, İzmir, 35170, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof. Dr

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 25, 2019

Study Start

July 1, 2019

Primary Completion

July 30, 2019

Study Completion

October 15, 2019

Last Updated

June 7, 2021

Record last verified: 2021-06

Locations