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OpenTrials
Completed

NCT Number: NCT03812757

Supraclavicular Fossa US View for Catheter Positioning in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skånes universitetssjukhus

Lund, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Supraclavicular fossa US scanning

Diagnostic Test

As previously stated.

Primary outcomes

  1. Correct catheter tip positioning

    Time frame: Post-procedural x-ray (typically within 24 hours)

    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).

Secondary outcomes

  1. Mechanical complications within 24 hours

    Time frame: Within 24 hours after central venous catheterization

    Bleeding, cardiac arrhythmias, arterial puncture/cannulation, pneumothorax.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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