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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04224259
Other study ID # N201803005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2020
Est. completion date March 2021

Study information

Verified date December 2019
Source Taipei Medical University WanFang Hospital
Contact Wei-Chen Chung, Dr.
Phone +886965562781
Email elizabethp215@yahoo.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date March 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound pre-scan
Before cannulation, use ultrasound to mark the position of right internal jugular vein
Landmark guidance
The traditional landmark-guided technique for internal jugular vein cannulation, including recognizing the sternocleidomastoid muscle and palpating the carotid artery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 first attempt success rate successfully access the internal jugular vein at first attempt During the cannulation procedure
Secondary artery puncture accidental artery puncture During the cannulation procedure
Secondary number of wire attempt how many times of the wire attempts before successful wire insertion to internal jugular vein During the cannulation procedure
Secondary number of skin insertion how many different skin insertion sites were tried before successfully access the internal jugular vein During the cannulation procedure
Secondary venous access time How long does it take from the first skin insertion to success venous access During the cannulation procedure
Secondary catheterization time How long does it take from the first skin insertion to successful catheter cannulation During the cannulation procedure
Secondary malposition the catheter misplaced to wrong sites (e.g. artery, subcutaneous) During the cannulation procedure
Secondary 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
Secondary other complication Other complications related to the procedure, such as pneumothorax during the procedure, and 1 day after the procedure
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