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

NCT03879954 | Completed

• 1 other identifier: UTEM SSCV
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Venous Catheter

Outcome Measures

Primary Outcomes (1)

• The overall access time

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

  During the venous cannulation procedure

Secondary Outcomes (2)

• The guidewire time

  During the venous cannulation procedure

• The venous access time

  During the venous cannulation procedure

Study Arms (2)

OOP-IJV

OTHER

Out of plane inetrnal jugular vein catetherization

Device: Catetherization approach

IP-SSV

OTHER

in plane supraclavicular subclavian vein catetherization

Device: Catetherization approach

Interventions

Catetherization approach DEVICE

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

IP-SSV; OOP-IJV

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted in intensive care unit requiring a central venous catheter (CVC)

You may not qualify if:

• Major blood coagulation disorders,
• Any thrombotic formations within the vein,
• Congenital or acquired deformity of neck or clavicle
• Cannulation site infection, hematoma and surgery.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Mrezga Nabeul Tunisie

Nabeul, 8000, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 36183049 DERIVED

Study Officials

• BEN ALI MECHAAL, PROFESSOR

  University Tunis El Manar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 19, 2019
• Study Start: February 26, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

TU (1)