SC vs IC Approach for US-guided SC Vein Catheterization

NCT ID: NCT04637347

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Central Venous Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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IP-ISV

In plane infraclavicular subclavian vein catheterization

Group Type OTHER

Catheterization approach

Intervention Type DEVICE

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

IP-SSV

In plane supraclavicular subclavian vein catetherization

Group Type OTHER

Catheterization approach

Intervention Type DEVICE

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

Interventions

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Catheterization approach

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

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Trabelsi Becem

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BEN ALI MECHAAL, PROFESSOR

Role: STUDY_CHAIR

University Tunis El Manar

Locations

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Mrezga Nabeul Tunisie

Nabeul, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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CIS UTSCVC

Identifier Type: -

Identifier Source: org_study_id

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