- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556770
Sonographic Safety Margins of Subclavian Vein: Effect of View and Arm Position
Observational Ultrasound Study of Subclavian Vein Anatomy: Comparison of Safety Margins Between Supraclavicular and Infraclavicular Positions According to 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jun-Young Park, MD, PhD
- Phone Number: 82-10-9920-0532
- Email: parkjy@amc.seoul.kr
Study Locations
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-
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Seoul, South Korea, 05505
- Asan Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observation Group
Adult patients undergoing general anesthesia who are scheduled for ultrasound-guided vascular catheterization.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately after the induction of general anesthesia (within 3 to 5 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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Immediately after the induction of general anesthesia (within 3 to 5 minutes)
|
|
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).
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Immediately after the induction of general anesthesia (within 3 to 5 minutes)
|
|
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).
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Immediately after the induction of general anesthesia (within 3 to 5 minutes)
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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)
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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).
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Immediately after the induction of general anesthesia (within 3 to 5 minutes)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
- Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.
- Vezzani A, Manca T, Brusasco C, Santori G, Cantadori L, Ramelli A, Gonzi G, Nicolini F, Gherli T, Corradi F. A randomized clinical trial of ultrasound-guided infra-clavicular cannulation of the subclavian vein in cardiac surgical patients: short-axis versus long-axis approach. Intensive Care Med. 2017 Nov;43(11):1594-1601. doi: 10.1007/s00134-017-4756-6. Epub 2017 Mar 13.
- Raad I. Intravascular-catheter-related infections. Lancet. 1998 Mar 21;351(9106):893-8. doi: 10.1016/S0140-6736(97)10006-X. No abstract available.
- Byon HJ, Lee GW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Comparison between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in children--a randomized trial. Br J Anaesth. 2013 Nov;111(5):788-92. doi: 10.1093/bja/aet202. Epub 2013 Jun 10.
- Vogel JA, Haukoos JS, Erickson CL, Liao MM, Theoret J, Sanz GE, Kendall J. Is long-axis view superior to short-axis view in ultrasound-guided central venous catheterization? Crit Care Med. 2015 Apr;43(4):832-9. doi: 10.1097/CCM.0000000000000823.
- Safdar N, Kluger DM, Maki DG. A review of risk factors for catheter-related bloodstream infection caused by percutaneously inserted, noncuffed central venous catheters: implications for preventive strategies. Medicine (Baltimore). 2002 Nov;81(6):466-79. doi: 10.1097/00005792-200211000-00007.
- Saugel B, Scheeren TWL, Teboul JL. Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice. Crit Care. 2017 Aug 28;21(1):225. doi: 10.1186/s13054-017-1814-y.
- Comerlato PH, Rebelatto TF, Santiago de Almeida FA, Klein LB, Boniatti MM, Schaan BD, Rados DV. Complications of central venous catheter insertion in a teaching hospital. Rev Assoc Med Bras (1992). 2017 Jul;63(7):613-620. doi: 10.1590/1806-9282.63.07.613.
- Sadek M, Roger C, Bastide S, Jeannes P, Solecki K, de Jong A, Buzancais G, Elotmani L, Ripart J, Lefrant JY, Bobbia X, Muller L. The Influence of Arm Positioning on Ultrasonic Visualization of the Subclavian Vein: An Anatomical Ultrasound Study in Healthy Volunteers. Anesth Analg. 2016 Jul;123(1):129-32. doi: 10.1213/ANE.0000000000001327.
- Prasad R, Soni S, Janweja S, Rajpurohit JS, Nivas R, Kumar J. Supraclavicular or infraclavicular subclavian vein: Which way to go- A prospective randomized controlled trial comparing catheterization dynamics using ultrasound guidance. Indian J Anaesth. 2020 Apr;64(4):292-298. doi: 10.4103/ija.IJA_930_19. Epub 2020 Mar 28.
- Jaiswal P, Saini S, Chhabra PH. Subclavian Vein Cannulation via Supraclavicular or Infraclavicular Route Which is Better? A Prospective Randomized Controlled Trial. Indian J Crit Care Med. 2024 Apr;28(4):375-380. doi: 10.5005/jp-journals-10071-24686.
- Bojic A, Steiner I, Gamper J, Schellongowski P, Lamm W, Hermann A, Riss K, Robak O, Staudinger T. Supraclavicular Approach to the Subclavian Vein as an Alternative Venous Access Site for ECMO Cannulae? A Retrospective Comparison. ASAIO J. 2017 Sep/Oct;63(5):679-683. doi: 10.1097/MAT.0000000000000529.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026-0533
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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