NCT05717556

Brief Summary

Internal jugular vein cannulation can be performed with the blind technique under ultrasound (USG) guidance or using classical marker points. It has been shown that USG-guided interventions reduce the complication rate compared to the method performed with the blind technique (4%/13.5%). In addition, the initial entry success rate in the USG supported group is 65%. , this rate remained at 45% with the blind technique. Although Pleth variability index monitoring is a noninvasive method, it is a technique that consistently predicts fluid sensitivity in patients under mechanical ventilation. The aim of study is before applying USG guided catheterization; We think that by revealing the factors of the patient that are effective on the number of interventions, necessary measures can be taken for the success of catheterization as a result.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

January 31, 2023

Last Update Submit

February 4, 2023

Conditions

UltrasoundCatheterizationVolume Status

Keywords

juguler vein catheterizationultrasound guidancepleth variability index

Outcome Measures

Primary Outcomes (4)

  • factors of internal vein jugular catheterization success

    neck circumference,

    Baseline (Before catheterization)

  • factors of internal vein jugular catheterization success

    internal juguler vein depth

    Baseline (Before catheterization)

  • factors of internal vein jugular catheterization success

    internal vein diameter

    Baseline (Before catheterization)

  • factors of internal vein jugular catheterization success

    pleth variability index

    Baseline (Before catheterization)

Study Arms (2)

single attempt catheterization

ACTIVE COMPARATOR

successful catheterization with a single attempt number

Procedure: Internal Jugular Vein Catheterization

multiple attempts catheterization

ACTIVE COMPARATOR

successful catheterization after multiple attempts

Procedure: Internal Jugular Vein Catheterization

Interventions

Internal Jugular Vein CatheterizationPROCEDURE

Inserting a cannula into the internal jugular vein

multiple attempts catheterizationsingle attempt catheterization

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-75
  • underwent coronary artery bypass surgery

You may not qualify if:

  • \<18 years old
  • Hemodynamic instability
  • Use of inotropic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zonguldak Bülent Ecevit University Faculty of Medicine

Kozlu, Esenköy, 67600, Turkey (Türkiye)

Location

Zongulak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 8, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

January 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)