NCT04224259

Brief Summary

This study aims to define a simple, safe, and effective ultrasound pre-scan technique for right internal jugular vein (RIJV) cannulation. After placing the patient properly, the operator puts a linear ultrasound probe at the mid neck in short-axis view. With the IVJ in the center of the screen, the operator makes marks at both ends of the transducer (mark A and B), and then rotates the transducer 90 degrees counterclockwise. After finding IJV in long-axis view with transducer vertical to the ground, other two marks are made at both ends of the transducer (mark C and D). After proper preparation, the operator recognizes the cross point made by the imagined lines of marks AB and marks CD (point E). The needle is inserted vertically to the ground at point E. Inclusion criteria are adult patients receiving general anesthesia in need of central venous cannulation.The primary endpoint is the number of needle redirection, and secondary endpoints include first attempt success rate, artery puncture, complication, number of wire attempt, number of skin insertion, venous access time, catheterization time, and malposition. The hypothesis is that this ultrasound pre-scan method would have a fewer number of needle redirection, a higher first-attempt success rate, as well as less complication, number of redirection.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 13, 2020

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

October 28, 2019

Last Update Submit

January 8, 2020

Conditions

Keywords

Ultrasoundpre-scanright internal jugular vein

Outcome Measures

Primary Outcomes (1)

  • number of needle redirection

    How many times of the needle being withdrawn and redirected before successfully access internal jugular vein

    During the cannulation procedure

Secondary Outcomes (9)

  • first attempt success rate

    During the cannulation procedure

  • artery puncture

    During the cannulation procedure

  • number of wire attempt

    During the cannulation procedure

  • number of skin insertion

    During the cannulation procedure

  • venous access time

    During the cannulation procedure

  • +4 more secondary outcomes

Study Arms (2)

ultrasound pre-scan group

EXPERIMENTAL

Perform ultrasound pre-scan before central venous cannulation

Procedure: Ultrasound pre-scan

landmark guidance group

SHAM COMPARATOR

Use the traditional landmark method to perform central venous cannulation

Procedure: Landmark guidance

Interventions

Before cannulation, use ultrasound to mark the position of right internal jugular vein

ultrasound pre-scan group

The traditional landmark-guided technique for internal jugular vein cannulation, including recognizing the sternocleidomastoid muscle and palpating the carotid artery

landmark guidance group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 20 years and younger than 80 years of age
  • American Society of Anesthesiologists Physical Status Classification I-III (no immediate life-threatening condition)
  • Scheduled for regular surgery
  • Receive general anesthesia with endotracheal tube intubation
  • In need of central venous catheter placement

You may not qualify if:

  • Body Mass Index \> 35kg/m\^2
  • Abnormal anatomy of the neck
  • Limited range of motion of the neck
  • The surgery does not allow right internal jugular vein cannulation or other contraindications for the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schummer W, Koditz JA, Schelenz C, Reinhart K, Sakka SG. Pre-procedure ultrasound increases the success and safety of central venous catheterizationdagger. Br J Anaesth. 2014 Jul;113(1):122-9. doi: 10.1093/bja/aeu049. Epub 2014 Mar 18.

    PMID: 24648131BACKGROUND

Study Officials

  • Jui-An Lin, Dr.

    Doctor

    STUDY CHAIR

Central Study Contacts

Wei-Chen Chung, Dr.

CONTACT

Jui-An Lin, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

January 13, 2020

Study Start

February 1, 2020

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

January 13, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

There's no plan of sharing individual participant data currently