SC vs IC Approach for US-guided SC Vein Catheterization

Central Venous Catheter Clinical Trial

— USIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637347
• Other study ID #: CIS UTSCVC
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Catheter

Intervention

Device:
• Catheterization approach
In plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization

Locations

Country	Name	City	State
Tunisia	Mrezga Nabeul Tunisie	Nabeul

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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