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General Anesthesia Induction for Elective SurgeryNCT07556770

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

An observational study of General Anesthesia Induction for Elective Surgery and Sono Guided Catheterization, run by Asan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 79 years
What is being tested?
Non-invasive sonographic observation
How many people
55 participants
Where
1 siteSouth Korea
Study dates
30 Apr 2026to 10 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Need for ultrasound-guided vascular access for general anesthesia

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Non-invasive sonographic observation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-invasive sonographic observationOther

    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.

Study groups in NCT07556770
Study groupRoleWhat they receive
Observation GroupAdult patients undergoing general anesthesia who are scheduled for ultrasound-guided vascular catheterization.
Receives: Other: Non-invasive sonographic observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (4)
  1. 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).

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

  2. 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).

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

  3. 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).

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

  4. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start30 Apr 2026
  3. Primary completion10 Jun 2026
  4. Study completion10 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07556770
Sponsor's protocol ID
2026-0533
Status last verified
Jun 2026
First submitted
22 Apr 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 12646670
  • 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.

    PubMed 28844205
  • 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.

    PubMed 28977087
  • 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.

    PubMed 27149016
  • 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.

    PubMed 28289815
  • 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.

    PubMed 32489203
  • 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.

    PubMed 38585307
  • 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.

    PubMed 23756247
  • 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.

    PubMed 28125465
  • 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.

    PubMed 12441903
  • 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.

    PubMed 26398070
  • 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.

    PubMed 25517477
  • 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.

    PubMed 9525387

Questions about this trial

What is this clinical trial studying?

An observational study of General Anesthesia Induction for Elective Surgery and Sono Guided Catheterization, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07556770, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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