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Completed

NCT Number: NCT03879954

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

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.

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Key information

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) 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.

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

Catetherization approach

Device

Out of plane inetrnal jugular 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.

Secondary outcomes

  1. 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.

  2. The venous access time

    Time frame: During the venous cannulation procedure

    The 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

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

Acronym: IPSSCVC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Dec 17, 2019

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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