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

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ClinicalTrials.gov Identifier: NCT04637347
Recruitment Status : Completed
First Posted : November 19, 2020
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Trabelsi Becem, University Tunis El Manar

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Central Venous Catheter Device: Catheterization approach Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Comparaison Between Ultrasound-guided Supraclavicular and Infraclavicular Approaches for Subclavian Venous Catheterization in Intensive Care Unit
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : May 31, 2021
Actual Study Completion Date : June 30, 2021
Arms and Interventions
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Arm Intervention/treatment
IP-ISV
In plane infraclavicular subclavian vein catheterization
 Device: Catheterization approach
In plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization
IP-SSV
In plane supraclavicular subclavian vein catetherization
 Device: Catheterization approach
In plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04637347


Locations
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Tunisia
Mrezga Nabeul Tunisie
Nabeul, Tunisia, 8000
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Study Chair: BEN ALI MECHAAL, PROFESSOR University Tunis El Manar
More Information
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Responsible Party: Trabelsi Becem, associate professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT04637347    
Other Study ID Numbers: CIS UTSCVC
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No