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Completed

NCT Number: NCT07556770

Sonographic Safety Margins of Subclavian Vein: Effect of View and Arm Position

The purpose of this observational study is to evaluate and compare the anatomical safety margins of the subclavian vein using ultrasound. Medical professionals commonly use the subclavian vein to insert central venous catheters, but nearby vulnerable structures, such as the lung and artery, can be at risk during the procedure.

This study investigates two different ultrasound probe positions: supraclavicular (above the collarbone) and infraclavicular (below the collarbone). It also examines how changing the patient's arm position (from resting in a neutral position to being raised at a 90-degree angle) affects the distance between the vein and these vulnerable structures.

Participants are adult patients scheduled for surgery under general anesthesia who already require ultrasound-guided vascular access. Immediately after falling asleep from anesthesia, researchers will perform a brief 3 to 5-minute ultrasound scan of the collarbone area. This is a strictly non-invasive imaging study; no research-related needle punctures or catheter insertions will be performed. The findings aim to provide robust anatomical evidence to make future vascular procedures safer for patients.

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

Central venous catheterization via the subclavian vein (SCV) is clinically favored due to its lower infection and thrombosis rates. However, traditional landmark-guided approaches carry the risk of mechanical complications, including pneumothorax and inadvertent arterial puncture. While real-time ultrasound guidance is strongly recommended to minimize these risks, there is an ongoing debate regarding the optimal probe position-specifically, the supraclavicular (SC) versus the infraclavicular (IC) view. Furthermore, clinical practitioners frequently utilize arm abduction to facilitate venous access, yet its dynamic effect on the anatomical safety margin (the distance between the SCV and adjacent vulnerable structures like the subclavian artery [SCA] and pleura) remains insufficiently quantified.

This prospective, non-invasive observational study aims to address this knowledge gap. The study will enroll 55 adult patients scheduled to undergo

Study Protocol:

Timing: Immediately following the induction of general anesthesia, during the standard pre-procedural preparation period, a brief (approximately 3 to 5 minutes) ultrasound assessment will be conducted.

Imaging: An investigator will obtain short-axis ultrasound views of the SCV from both the SC and IC positions.

Positioning: In each ultrasound view, measurements will be recorded under two different patient arm positions: neutral (adducted alongside the torso) and 90-degree abduction.

Data Acquisition: All ultrasound images will be captured at the end-expiratory phase and saved for offline analysis.

Safety: The study involves solely non-invasive sonographic observation; no research-specific needle puncture, cannulation, or catheterization will be performed. Routine scheduled clinical care and procedures will proceed immediately after the brief image acquisition is complete.

By analyzing sonographic parameters such as the SCV-SCA distance, vessel cross-sectional areas, depth to the pleura, and the SCV-SCA overlap index, this study seeks to elucidate the most secure anatomical window. Ultimately, the data will establish safer, evidence-based guidelines for patient positioning and ultrasound probe placement during SCV access.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients requiring ultrasound-guided vascular procedures.
  • Age between 20 and 79 years.
  • Patients who have voluntarily provided written informed consent for this clinical study.
  • American Society of Anesthesiologists (ASA) physical status classification I, II, or III.

Exclusion criteria

  • Anatomical variations of the clavicle (e.g., history of clavicle fracture).
  • Suspected thrombosis at the target site.
  • Known anatomical abnormalities of the subclavian vein or artery.
  • Inability to abduct the arm (e.g., due to shoulder joint abnormalities).
  • Patient refusal to participate.

Treatment and study plan

Non-invasive sonographic observation

Other

Non-invasive ultrasound measurement of anatomical safety margins of the subclavian vein and adjacent structures, comparing supraclavicular and infraclavicular views in neutral and abducted arm positions.

Primary outcomes

  1. Shortest Distance Between the Subclavian Vein (SCV) and Subclavian Artery (SCA)

    Time frame: Immediately after the induction of general anesthesia (within 3 to 5 minutes)

    The shortest anatomical distance between the SCV and SCA is measured in the neutral arm position to evaluate the safety margin. The difference between the supraclavicular (SC) and infraclavicular (IC) views will be analyzed using a paired t-test or Wilcoxon signed-rank test.

Secondary outcomes

  1. Sonographic Continuous Variables of the SCV and Adjacent Structures

    Time frame: Immediately after the induction of general anesthesia (within 3 to 5 minutes)

    The following continuous variables will be measured: 1) distance between SCV and SCA, 2) distance from skin to the anterior and posterior walls of SCV, 3) distance from SCV posterior wall to the pleura. These parameters will be analyzed using a two-way repeated measures ANOVA to assess the effects of the probe view (SC vs. IC) and arm position (neutral vs. abduction).

  2. Sonographic Cross-Sectional Area (CSA) Variables of the SCV and Adjacent Structures

    Time frame: Immediately after the induction of general anesthesia (within 3 to 5 minutes)

    The following continuous variables regarding area and dimension will be measured: 1) transverse length and cross-sectional area (CSA) of the SCV, and 2) CSA of the SCA. These parameters will be analyzed using a two-way repeated measures ANOVA to assess the effects of the probe view (SC vs. IC) and arm position (neutral vs. abduction).

  3. Sonographic Proportion and Index Variables of the SCV and Adjacent Structures

    Time frame: Immediately after the induction of general anesthesia (within 3 to 5 minutes)

    The following continuous variables regarding proportions will be measured: 1) SCV-SCA overlap index (%), and 2) clavicle shadowing proportion (%). These parameters will be analyzed using a two-way repeated measures ANOVA to assess the effects of the probe view (SC vs. IC) and arm position (neutral vs. abduction).

  4. Relative Position of the Subclavian Artery (SCA) to the Subclavian Vein (SCV)

    Time frame: Immediately after the induction of general anesthesia (within 3 to 5 minutes)

    A nominal variable describing the anatomical location of the SCA relative to the SCV (e.g., medial, posteromedial, posterior). The distribution changes according to the probe view (SC vs. IC) and arm position (neutral vs. abduction) will be compared using Generalized Estimating Equations (GEE).

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Observational Ultrasound Study of Subclavian Vein Anatomy: Comparison of Safety Margins Between Supraclavicular and Infraclavicular Positions According to Arm Position

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Jun 15, 2026

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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