Ultrasound Pre-scan to Reduce Needle Redirection During Right Jugular Vein Cannulation

Utility of Vertical Puncture Technique Assisted by Ultrasound Pre-scan to Reduce Needle Redirection During Right Jugular Vein Cannulation

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Ultrasound pre-scan; Procedure: Landmark guidance

Detailed Description

Ultrasound-guided central venous cannulation has been widely used because of lower technical failure rate and complications, and faster access compared with landmark-guided cannulation. Real-time guidance is more complex to perform and time-consuming in comparison to pre-scan technique. Therefore, real-time guidance should be reserved to specific groups, such as infants, children, or those with anatomical abnormality. However, there's no widely accepted ultrasound pre-scan techniques yet. The aim of this study is to define a simple, safe, and effective ultrasound pre-scan technique for right internal jugular vein (RIJV) cannulation.

Patient position for RIJV cannulation was reviewed in detail. First, 15ﾟ Trendelenburg tilt significantly increases the diameter of right internal jugular vein. Second, extreme head rotation to the opposite side will increase the overlap percentage between IJV and common carotid artery (CCA), but neutral head position might make the procedure difficult. Neutral head position or small degree (≦15ﾟ) of head rotation was recommended. Third, although shoulder roll is not recommended since it decreases the anterior-posterior diameter of RIJV, 4- to 5cm-high shoulder roll could be used to reduce the overlap if needed10. In conclusion, patients should be positioned by a 15ﾟ Trendelenburg tilt and 15ﾟ head rotation to the opposite side without a shoulder roll unless the IJV is anterior to CCA, which was termed as the rule of 15 by the research team.

After placing the patient properly, the operator puts a linear ultrasound probe at the mid neck in short-axis view. With IVJ in the center of the screen, marks at both ends of the transducer (mark A and B) are made. Then the operator rotates 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), and transducer and jelly are removed. Then the operator sterilizes the performing field with chlorhexidine without removing the marks. After proper preparation and recognizing the cross point made by the imagined lines of marks AB and marks CD (point E), the operator inserts the needle vertically to the ground at point E.

The aim of this study is to compare the effectiveness and safety between ultrasound pre-scan technique and traditional landmark-guidance. 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 the 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei-Chen Chung, Dr.; Phone Number: +886965562781; Email: elizabethp215@yahoo.com.tw
• Study Contact Backup: Name: Jui-An Lin, Dr.; Phone Number: +886970746115; Email: juian.lin@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasound pre-scan group; Perform ultrasound pre-scan before central venous cannulation	Procedure: Ultrasound pre-scan; Before cannulation, use ultrasound to mark the position of right internal jugular vein
Sham Comparator: landmark guidance group; Use the traditional landmark method to perform central venous cannulation	Procedure: Landmark guidance; The traditional landmark-guided technique for internal jugular vein cannulation, including recognizing the sternocleidomastoid muscle and palpating the carotid artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
first attempt success rate	successfully access the internal jugular vein at first attempt	During the cannulation procedure
artery puncture	accidental artery puncture	During the cannulation procedure
number of wire attempt	how many times of the wire attempts before successful wire insertion to internal jugular vein	During the cannulation procedure
number of skin insertion	how many different skin insertion sites were tried before successfully access the internal jugular vein	During the cannulation procedure
venous access time	How long does it take from the first skin insertion to success venous access	During the cannulation procedure
catheterization time	How long does it take from the first skin insertion to successful catheter cannulation	During the cannulation procedure
malposition	the catheter misplaced to wrong sites (e.g. artery, subcutaneous)	During the cannulation procedure
presence of hematoma	a different and blinded investigator reviewed the post-procedure ultrasound image to determine whether there is hematoma after the procedure	immediately at the end of procedure, evaluated by clinical signs and ultrasound image
other complication	Other complications related to the procedure, such as pneumothorax	during the procedure, and 1 day after the procedure

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Study Chair: Jui-An Lin, Dr., Doctor

Publications and helpful links

General Publications

• 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.

Helpful Links

• Is " real-time " ultrasound guidance always necessary for internal jugular vein cannulation in anatomically normal adults?

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; pre-scan; right internal jugular vein
• Other Study ID Numbers: N201803005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There's no plan of sharing individual participant data currently

Drug and device information, study documents

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