NCT07556770

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 22, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 22, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Sonographic Continuous Variables of the SCV and Adjacent Structures

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

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

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

  • Sonographic Proportion and Index Variables of the SCV and Adjacent Structures

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

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

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

Study Arms (1)

Observation Group

Adult patients undergoing general anesthesia who are scheduled for ultrasound-guided vascular catheterization.

Other: Non-invasive sonographic observation

Interventions

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.

Observation Group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Need for ultrasound-guided vascular access for general anesthesia

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (13)

  • 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.

    PMID: 12646670BACKGROUND
  • 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.

    PMID: 28844205BACKGROUND
  • 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.

    PMID: 28977087BACKGROUND
  • 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.

    PMID: 27149016BACKGROUND
  • 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.

    PMID: 28289815BACKGROUND
  • 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.

    PMID: 32489203BACKGROUND
  • 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.

    PMID: 38585307BACKGROUND
  • 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.

    PMID: 23756247BACKGROUND
  • 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.

    PMID: 28125465BACKGROUND
  • 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.

    PMID: 12441903BACKGROUND
  • 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.

    PMID: 26398070BACKGROUND
  • 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.

    PMID: 25517477BACKGROUND
  • 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.

    PMID: 9525387BACKGROUND

Central Study Contacts

Jun-Young Park, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 22, 2026

First Posted

April 29, 2026

Study Start

April 23, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations