SC vs IC Approach for US-guided SC Vein Catheterization

NCT04637347 | Completed

• 1 other identifier: CIS UTSCVC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheter

Outcome Measures

Primary Outcomes (3)

• 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

• The guidewire time

  Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire into the vein

  During the venous cannulation procedure

• The venous access time

  he time between the first skin puncture and free aspiration of venous blood in the syringe

  During the venous cannulation procedure

Study Arms (2)

IP-ISV

OTHER

In plane infraclavicular subclavian vein catheterization

Device: Catheterization approach

IP-SSV

OTHER

In plane supraclavicular subclavian vein catetherization

Device: Catheterization approach

Interventions

Catheterization approach DEVICE

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

IP-ISV; IP-SSV

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

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: November 14, 2020
• First Posted: November 19, 2020
• Study Start: December 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

TU (1)