NCT07396961

Brief Summary

Tuffier's line is commonly used as a landmark for estimating lumbar vertebral levels during spinal anesthesia. However, its accuracy can vary depending on factors such as age, sex, BMI, and posture. This study evaluates the consistency of an alternative landmark, the "ASIS line" (a line connecting both Anterior Superior Iliac Spines), for identifying lumbar levels in the lateral decubitus position. Researchers will mark both the ASIS line and Tuffier's line on participants and use ultrasound to verify the exact vertebral level where each line crosses the spine. The goal is to determine if the ASIS line provides a more consistent and reliable estimation of lumbar levels compared to Tuffier's line.

Trial Health

63
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Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Feb 2028

First Submitted

Initial submission to the registry

January 30, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2028

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 30, 2026

Last Update Submit

January 30, 2026

Conditions

Keywords

vertebral levelUltrasoundTuffier's lineASISLateral decubitus position

Outcome Measures

Primary Outcomes (1)

  • Consistency of Vertebral Level Identification (Standard Deviation)

    The specific vertebral level where the ASIS line and Tuffier's line intersect the spine will be identified using ultrasound. The lumbar spine (from L2 upper to S1 upper) is divided into segments (e.g., L2=2, L3=3, L4=4, L5=5, S1=6). The consistency of each method is evaluated by calculating and comparing the standard deviation (SD) of the identified vertebral levels.

    Day 1 (Immediately during the ultrasound examination)

Secondary Outcomes (2)

  • Difference in Mean Intersection Level

    Day 1

  • Rate of Identification within L4-L5 Interspace

    Day 1

Study Arms (1)

Study Cohort

Adult patients (aged 18-85) scheduled for spinal anesthesia or lumbar ultrasound

Diagnostic Test: Lumbar Ultrasound & Palpation

Interventions

Identification of vertebral levels using Tuffier's line (palpation) and ASIS line, followed by ultrasound verification.

Study Cohort

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients visiting the study centers (Kangbuk Samsung Hospital or St. Vincent's Hospital) who are scheduled for spinal anesthesia or lumbar ultrasound.

You may qualify if:

  • Adults aged 18 to 85 years
  • Patients scheduled for spinal anesthesia or lumbar ultrasound
  • Participants who voluntarily agreed to participate and provided written informed consent

You may not qualify if:

  • History of spinal surgery or spinal deformity
  • Infection or wounds at the puncture site
  • Inability to maintain the lateral decubitus position
  • Congenital lumbosacral transitional vertebrae (e.g., sacralized L5 or lumbarized S1)
  • Any other condition deemed unsuitable for the study by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Vincent's Hospital

Suwon, North Carolina, 27516, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Interventions

Palpation

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Sung Hyun Lee, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 9, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2028

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations