Supraclavicular Fossa US View for Catheter Positioning in Right Subclavian Central Venous Catheterization

The Supraclavicular Fossa Ultrasound View for Correct Catheter Positioning in Infraclavicular Right Subclavian Central Venous Catheterization

The study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a correct catheter tip placement in infraclavicular right subclavian central venous catheter placement. This may make routine post-procedural x-ray exams redundant.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheter Placement
• Intervention / Treatment: Diagnostic test: Supraclavicular fossa US scanning

Detailed Description

Central venous catheterization is one of the most common procedures within intensive care medicine. Verification of correct catheter tip placement is a primary aspect of safety and quality of central venous catheterization as malposition may lead to life-threatening complications such as thrombosis, hemothorax, cardiac tamponade, and arrhythmias. Conventional chest x-ray (CXR) is routinely performed after every insertion and is considered gold standard to examine catheter tip location and evaluate for complications such as pneumo- and hemothorax. However, CXR exposes the patient to ionized radiation, requires a considerable amount of time, and is workload-generating for both ICU and radiology staff.

Weber et al has described the use of the right supraclavicular fossa view for real-time ultrasound-guided placement of a central venous catheter (CVC) via the right internal jugular vein (IJV) in adults. This approach has subsequently been validated in a clinical study and has also been used for supraclavicular subclavian line insertion. The approach requires use of a microconvex probe, which couples good image resolution and high scanning depth. The use of a microconvex probe for infraclavicular subclavian central venous catheter (CVC) insertion has been described previously, but this is the first description of the supraclavicular fossa ultrasound view to guide correct catheter tip placement in infraclavicular right subclavian CVC placement.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Skånes Universitetssjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients >18 years with an indication for CVC placement and under the care of one of three intensivists responsible for the study will be consecutively included in the study

Description

Inclusion Criteria:

• Indication for central venous catheter placement.

Exclusion Criteria:

• Operator unable to visualize the subclavian vein (e.g., in those with subcutaneous emphysema of the chest wall),
• Subclavian vein catheterization deemed inappropriate by the operator,
• Central line/pacemaker/similar device already in place (risk for misinterpretation of the ultrasound image)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Supraclavicular fossa US scanning; Following insertion of at least 20 cm of the guidewire into the right subclavian vein, the probe is shifted to the right supraclavicular fossa to scan the right internal jugular vein in order to exclude malposition of the guidewire. The probe is then tilted in a caudal direction to obtain a view of the guidewire within the superior vena cava. Misplaced guidewires will be corrected under real-time ultrasound guidance.

Diagnostic test: Supraclavicular fossa US scanning; As previously stated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct catheter tip positioning	Optimal placement (cavoatrial junction, distal superior vena cava); acceptable placement (upper part of the right atrium and entire SVC, provided that the axes of the catheter and vein are aligned to reduce the risk of vessel perforation); unacceptable placement (all other locations).	Post-procedural x-ray (typically within 24 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical complications within 24 hours	Bleeding, cardiac arrhythmias, arterial puncture/cannulation, pneumothorax.	Within 24 hours after central venous catheterization

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Investigators: Principal Investigator: Ola Borgquist, MD, PhD, Skane University Hospital

Publications and helpful links

General Publications

• Adrian M, Kander T, Lunden R, Borgquist O. The right supraclavicular fossa ultrasound view for correct catheter tip positioning in right subclavian vein catheterisation: a prospective observational study. Anaesthesia. 2022 Jan;77(1):66-72. doi: 10.1111/anae.15534. Epub 2021 Jul 14.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 19, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Central venous catheter; Subclavian vein; Supraclavicular fossa ultrasound view
• Other Study ID Numbers: CVC positioning

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No