US-guided OOP Internal Jugular Vein Vs IP Supraclavicular Subclavian Vein Catheterization in ICU (IPSSCVC)

Comparison Between Ultrasound-guided Out-of-plane Internal Jugular Vein and In-plane Supraclavicular Subclavian Vein Catheterization in Intensive Care Unit Patients-a Randomized Trial

Patients were randomly divided into two groups: ultrasound-guided (US-guided) out-of-plane internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.

For OOP-IJV cannulation, the transducer was placed to identify IJV in short-axis view. The needle was introduced at an angle of 60° to the skin surface, and advanced under real-time US guidance until visualizing the tip of the needle inside the vein.

For IP-SSV cannulation, a short-axis view of the IJV was obtained first. The probe was slid caudally following the IJV until getting the best long-axis view of the SCV. Using an in-plane approach, the needle was inserted at the base of the transducer at a 30° angle and advanced under the long axis under real-time US guidance targeting the SCV.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheter
• Intervention / Treatment: Device: Catetherization approach

Detailed Description

Patients were randomly divided into two groups: ultrasound-guided (US-guided) out-of-plane internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.

For OOP-IJV cannulation, the transducer was placed on transverse position over the patient's neck at the level of the cricoid cartilage to identify IJV and carotid artery (CA) in short-axis view. The vein was then centered on the screen. The skin puncture was made in the center of the US image using a needle attached to a syringe. The needle was introduced at an angle of 60° to the skin surface, perpendicular to the transducer, and advanced under real-time US guidance toward the IJV until visualizing the tip of the needle inside the vein.

For IP-SSV cannulation, a short-axis view of the IJV was obtained first. The probe was slid caudally following the IJV until the junction of the subclavian vein (SCV) and IJV was reached in the supraclavicular fossa. The probe was then turned slightly and tilted anteriorly to get the best long-axis view of the SCV and the brachiocephalic vein (BCV).

Using an in-plane approach, the needle attached to a syringe was inserted at the base of the transducer at a 30° angle and advanced strictly under the long axis of the US probe from lateral to medial. The needle point was then guided under real-time US guidance targeting the SCV.

In both groups, catheterization was done through Seldinger technique.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Nabeul, Tunisia, 8000
    • Mrezga Nabeul Tunisie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients admitted in intensive care unit requiring a central venous catheter (CVC)

Exclusion Criteria:

• Major blood coagulation disorders,
• Any thrombotic formations within the vein,
• Congenital or acquired deformity of neck or clavicle
• Cannulation site infection, hematoma and surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: OOP-IJV; Out of plane inetrnal jugular vein catetherization	Device: Catetherization approach; Out of plane inetrnal jugular vein Vs in plane supraclavicular subclavian vein catetherization
Other: IP-SSV; in plane supraclavicular subclavian vein catetherization	Device: Catetherization approach; Out of plane inetrnal jugular vein Vs in plane supraclavicular subclavian vein catetherization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall access time	Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire into vein.	During the venous cannulation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The guidewire time	Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire into the vein.	During the venous cannulation procedure
The venous access time	The time between the first skin puncture and free aspiration of venous blood in the syringe	During the venous cannulation procedure

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Study Chair: BEN ALI MECHAAL, PROFESSOR, University Tunis El Manar

Publications and helpful links

General Publications

• Trabelsi B, Hajjej Z, Drira D, Yedes A, Labbene I, Ferjani M, Ben Ali M. Comparison of ultrasound-guided internal jugular vein and supraclavicular subclavian vein catheterization in critically ill patients: a prospective, randomized clinical trial. Ann Intensive Care. 2022 Oct 1;12(1):91. doi: 10.1186/s13613-022-01065-x.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Actual): November 26, 2019
• Study Completion (Actual): November 26, 2019

Study Registration Dates

• First Submitted: March 2, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UTEM SSCV

Drug and device information, study documents

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