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

NCT ID: NCT04224259

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-29
• Study Completion Date: 2021-03-31

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.

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

ultrasound pre-scan group

Perform ultrasound pre-scan before central venous cannulation

Group Type: EXPERIMENTAL

Ultrasound pre-scan

Intervention Type: PROCEDURE

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

landmark guidance group

Use the traditional landmark method to perform central venous cannulation

Group Type: SHAM_COMPARATOR

Landmark guidance

Intervention Type: PROCEDURE

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

Interventions

Ultrasound pre-scan

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

Intervention Type: PROCEDURE

Landmark guidance

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jui-An Lin, Dr.

Role: STUDY_CHAIR

Doctor

Central Contacts

Wei-Chen Chung, Dr.

Role: CONTACT

elizabethp215@yahoo.com.tw

+886965562781

Jui-An Lin, Dr.

Role: CONTACT

juian.lin@tmu.edu.tw

+886970746115

References

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.

Reference Type: BACKGROUND

PMID: 24648131 (View on PubMed)

Other Identifiers

N201803005

Identifier Type: -

Identifier Source: org_study_id