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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation Group | Adult patients undergoing general anesthesia who are scheduled for ultrasound-guided vascular catheterization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Shortest Distance Between the Subclavian Vein (SCV) and Subclavian Artery (SCA) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Sonographic Continuous Variables of the SCV and Adjacent Structures | 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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Inclusion Criteria:
Exclusion Criteria:
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Need for ultrasound-guided vascular access for general anesthesia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12646670 | Background | 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. | |
| 28844205 | Background | 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. |
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Individual participant data (IPD) will not be shared to protect patient privacy and confidentiality, in accordance with the Institutional Review Board (IRB) regulations. Only aggregated and anonymized data will be presented in the final publication.
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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 | 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). | Immediately after the induction of general anesthesia (within 3 to 5 minutes) |
| Sonographic Proportion and Index Variables of the SCV and Adjacent Structures | 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). | Immediately after the induction of general anesthesia (within 3 to 5 minutes) |
| Relative Position of the Subclavian Artery (SCA) to the Subclavian Vein (SCV) | 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). | Immediately after the induction of general anesthesia (within 3 to 5 minutes) |
| 28977087 | Background | 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. |
| 27149016 | Background | 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. |
| 28289815 | Background | 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. |
| 32489203 | Background | 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. |
| 38585307 | Background | 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. |
| 23756247 | Background | 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. |
| 28125465 | Background | 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. |
| 12441903 | Background | 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. |
| 26398070 | Background | 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. |
| 25517477 | Background | 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. |
| 9525387 | Background | 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. |