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Completed

NCT Number: NCT04637347

SC vs IC Approach for US-guided SC Vein Catheterization

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.

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Key information

Conditions

Central Venous Catheter

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mrezga Nabeul Tunisie

Nabeul, 8000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Catheterization approach

Device

In plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization

Primary outcomes

  1. The overall access time

    Time frame: During the venous cannulation procedure

    Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire into vein.

  2. The guidewire time

    Time frame: During the venous cannulation procedure

    Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire into the vein

  3. The venous access time

    Time frame: During the venous cannulation procedure

    he time between the first skin puncture and free aspiration of venous blood in the syringe

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Acronym: USIC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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