SC vs IC Approach for US-guided SC Vein Catheterization (USIC)

Comparaison Between Ultrasound-guided Supraclavicular and Infraclavicular Approaches for Subclavian Venous Catheterization in Intensive Care Unit

Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.

For IP-ISV cannulation, a linear transducer is placed in the infraclavicular fossa. After obtaining a long-axis view of the axillary vein and distal subclavian vein ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the vein while noticing the lung pleura underneath the vessels.

For IP-SSV cannulation, a short-axis view of the IJV is obtained first. The probe is slid caudally following the IJV until getting the best long-axis view of the SCV. Using an in-plane approach, the needle is 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: Catheterization approach

Detailed Description

Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.

For IP -ISV, the Linear transducer is placed perpendicularly and inferior to clavicle. Transverse (short axis) view of subclavian vein (SCV), subclavian artery (SCA) and pleura is first obtained. With SCV centrally positioned, the transducer is rotated 90° clockwise until longitudinal view of subclavian vein is obtained. Pulse-wave Doppler view of the SCV confirms non-pulsatile flow and identifies the vessel. The needle is than inserted in the midpoint of the small footprint transducer using the in-plane approach. The needle is advanced slowly, under real-time US guidance targeting the SCV, taking note of the lung pleura underneath the vessels.

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

Using an in-plane approach, the needle attached to a syringe is 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 is then guided.

In both groups, catheterization was done through Seldinger technique.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 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: IP-ISV; In plane infraclavicular subclavian vein catheterization	Device: Catheterization approach; In plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization
Other: IP-SSV; In plane supraclavicular subclavian vein catetherization	Device: Catheterization approach; In plane infraclavicular subclavian 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
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	he 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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 14, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CIS UTSCVC

Drug and device information, study documents

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