NCT07315451

Brief Summary

The aim of the study is to compare the lateral decubitus and upright sitting positions in determining the intervertebral space measured by ultrasound in participants whose body mass index was greater than 30 and older than eighteen years old. Additionally, comparison of the sagittal and long-axis paramedian oblique planes in determining the intervertebral space measured by ultrasound in this group of volunteers. Furthermore, assesment of the reliability of measurements performed by practitioners with varying levels of ultrasound experience.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress63%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

March 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

March 2, 2025

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of Lateral Decubitus and Upright Sitting Positions in Ultrasound Measurement of Intervertebral Space in Adults with a BMI Over 30

    The primary outcome of the study is to compare the lateral decubitus and upright sitting positions in determining the intervertebral space measured by ultrasound in participants whose body mass index was greater than 30

    Baseline

Secondary Outcomes (1)

  • Comparison of Sagittal and Paramedian Oblique Planes for Ultrasound Measurement of Intervertebral Space

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers who want to participate in the study will be included.

You may qualify if:

  • participants whose body mass index was greater than 30
  • participants older than eighteen years old.

You may not qualify if:

  • participants who have a history of lumbar surgery
  • participants who have an infection on the lombar region
  • pregnant volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Turkey (Türkiye)

Location

Related Publications (8)

  • Roberts and Hedges' Clinical Procedures in Emergency Medicine and Acute Care. Editors: Roberts, J. R., Custalow, C. B., & Thomsen, T. W. . Seventh edition. Philadelphia, PA: Elsevier

    BACKGROUND
  • Nomura JT, Leech SJ, Shenbagamurthi S, Sierzenski PR, O'Connor RE, Bollinger M, Humphrey M, Gukhool JA. A randomized controlled trial of ultrasound-assisted lumbar puncture. J Ultrasound Med. 2007 Oct;26(10):1341-8. doi: 10.7863/jum.2007.26.10.1341.

    PMID: 17901137BACKGROUND
  • Ferre RM, Sweeney TW. Emergency physicians can easily obtain ultrasound images of anatomical landmarks relevant to lumbar puncture. Am J Emerg Med. 2007 Mar;25(3):291-6. doi: 10.1016/j.ajem.2006.08.013.

    PMID: 17349903BACKGROUND
  • Stiffler KA, Jwayyed S, Wilber ST, Robinson A. The use of ultrasound to identify pertinent landmarks for lumbar puncture. Am J Emerg Med. 2007 Mar;25(3):331-4. doi: 10.1016/j.ajem.2006.07.010.

    PMID: 17349909BACKGROUND
  • Huang MY, Lin AP, Chang WH. Ultrasound-assisted localization for lumbar puncture in the ED. Am J Emerg Med. 2008 Oct;26(8):955-7. doi: 10.1016/j.ajem.2008.03.007. No abstract available.

    PMID: 18926360BACKGROUND
  • Furness G, Reilly MP, Kuchi S. An evaluation of ultrasound imaging for identification of lumbar intervertebral level. Anaesthesia. 2002 Mar;57(3):277-80. doi: 10.1046/j.1365-2044.2002.2403_4.x.

    PMID: 11892638BACKGROUND
  • Shi D, Perice L, Grimaldi C, Perera T, Nelson M. Ultrasound Measurement of the Intervertebral Space in the Lateral Recumbent Versus Sitting Positions. J Emerg Med. 2021 Dec;61(6):705-710. doi: 10.1016/j.jemermed.2021.07.015. Epub 2021 Aug 29.

    PMID: 34465511BACKGROUND
  • Andreas Dewitz, Robert A. Jones, Jessica G. Resnick, and Michael B. Stone. Additional Ultrasound-Guided Procedures. Ma and Mateer's Emergency Ultrasound. Editors: O John Ma; James R Mateer; Robert F Reardon; Scott Joing. Third Edition. New York : McGraw-Hill Education. 2014.

    BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Asst. Prof.

Study Record Dates

First Submitted

March 2, 2025

First Posted

January 2, 2026

Study Start

April 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations