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

NCT ID: NCT03879954

Last Updated: 2019-12-17

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

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2019-11-26

Brief Summary

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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.

Detailed Description

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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.

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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OOP-IJV

Out of plane inetrnal jugular vein catetherization

Group Type OTHER

Catetherization approach

Intervention Type DEVICE

Out of plane inetrnal jugular vein Vs in plane supraclavicular subclavian vein catetherization

IP-SSV

in plane supraclavicular subclavian vein catetherization

Group Type OTHER

Catetherization approach

Intervention Type DEVICE

Out of plane inetrnal jugular vein Vs in plane supraclavicular subclavian vein catetherization

Interventions

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Catetherization approach

Out of plane inetrnal jugular 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

References

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Trabelsi B, Hajjej Z, Drira D, Yedes A, Labbene I, Ferjani M, Ben Ali M. Comparison of ultrasound-guided internal jugular vein and supraclavicular subclavian vein catheterization in critically ill patients: a prospective, randomized clinical trial. Ann Intensive Care. 2022 Oct 1;12(1):91. doi: 10.1186/s13613-022-01065-x.

Reference Type DERIVED
PMID: 36183049 (View on PubMed)

Other Identifiers

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UTEM SSCV

Identifier Type: -

Identifier Source: org_study_id