- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07396961
Consistency of ASIS Line vs. Tuffier's Line for Lumbar Level Identification
January 30, 2026 updated by: Sung Hyun Lee, Kangbuk Samsung Hospital
Evaluation of the Consistency of the ASIS Line for Lumbar Level Identification in the Lateral Decubitus Position: Comparison With the Tuffier's Line
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sung Hyun Lee, MD, PhD
- Phone Number: +82-2-2001-1666
- Email: hoho4321.lee@samsung.com
Study Locations
-
-
-
Seoul, South Korea, 03181
- Kangbuk Samsung Hospital
-
Contact:
- Sung Hyun Ldd, MD, PhD
- Email: hoho4321.lee@samsung.com
-
-
North Carolina
-
Suwon, North Carolina, South Korea, 27516
- St. Vincent's Hospital
-
Contact:
- Yoo Jung Park
- Phone Number: + 82-31-249-8446
- Email: genial7@naver.com
-
Contact:
- SUNG HYUN LEE
- Phone Number: +82-1-2001-2323
- Email: 4321hoho@naver.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study Cohort
Adult patients (aged 18-85) scheduled for spinal anesthesia or lumbar ultrasound
|
Identification of vertebral levels using Tuffier's line (palpation) and ASIS line, followed by ultrasound verification.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Consistency of Vertebral Level Identification (Standard Deviation)
Time Frame: Day 1 (Immediately during the ultrasound examination)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Mean Intersection Level
Time Frame: Day 1
|
Comparison of the mean vertebral levels identified by the ASIS line versus Tuffier's line to determine if there is a significant difference in the average level indicated.
|
Day 1
|
|
Rate of Identification within L4-L5 Interspace
Time Frame: Day 1
|
The percentage of cases where the identified line falls within the target L4-L5 interspace (or within ±1 interspace range).
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 20, 2026
Primary Completion (Estimated)
February 20, 2027
Study Completion (Estimated)
February 20, 2028
Study Registration Dates
First Submitted
January 30, 2026
First Submitted That Met QC Criteria
January 30, 2026
First Posted (Actual)
February 9, 2026
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
January 30, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-01-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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