Spinal ColumnNCT07315451
Comparison of Lateral Decubitus and Upright Sitting Positions in Measuring Intervertebral Space Via Ultrasound in Obese Volunteers
An observational study of Spinal Column and Lumbar Puncture, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Column, Lumbar Puncture, Ultrasonography
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 31 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers who want to participate in the study will be included.
Who may be able to join
- participants whose body mass index was greater than 30
- participants older than eighteen years old.
Who cannot join
- participants who have a history of lumbar surgery
- participants who have an infection on the lombar region
- pregnant volunteers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The study will be conducted in the Emergency Medicine Clinic of University of Health Sciences Kocaeli City Hospital. Participants over the age of 18 with a body mass index (BMI) of 30 or higher presenting to the emergency department will be included. After providing verbal information about the study, written informed consent will be obtained from participants who agree to take part. Participants will be evaluated by attending physicians in the emergency department, who will then inform the study investigators.
The upright sitting position is defined as the patient sitting upright on the stretcher with their legs hanging down the side, feet not touching the ground, and arms extended forward for support. The lateral decubitus position is defined as the patient lying on their side with their shoulders and hips perpendicular to the stretcher, knees flexed, and pulled toward the chest.
The ultrasound applications will be performed by two study investigators: one emergency medicine specialist with advanced ultrasound training and one with basic ultrasound training. Measurements will be taken first in the participant's preferred position (upright sitting or lateral decubitus) and then in the alternate position.
Since the traditional method for identifying the lumbar puncture (LP) site-known as Tuffier's line (the midpoint of the line connecting both anterior superior iliac spines in the lumbar region)-can be misleading in obese patients, the application site will be determined via ultrasound. An Esaote MyLab™ Gamma ultrasound device will be used, with the Esaote SL1543 linear probe as the first choice. If the linear probe does not provide adequate depth due to obesity, the Esaote SP2730 curved probe will be used.
For ultrasound application, the probe will initially be placed transversely just above the intragluteal fold, with the indicator pointing to the patient's left shoulder. Once the midline is identified, measurements will be performed in two planes: sagittal and long-axis paramedian oblique.
For the sagittal plane, the probe will be rotated 90 degrees with the indicator pointing toward the patient's head.
For the long-axis paramedian oblique plane, the probe will also be rotated 90 degrees toward the head but moved 1-2 cm laterally from the midline and angled slightly medially.
The probe will then be moved superiorly until the L4-L5 interspinal space is identified. The intervertebral space is defined as the hypoechoic region between hyperechoic spinous processes. Measurements will be taken from the L4-L5 and L3-L4 intervertebral spaces.
Each practitioner's measurements will include the distance to the ligamentum flavum, as well as data on whether the patient has undergone lumbar surgery, and their weight and height. These will be recorded in a pre-prepared standard data form. Practitioners will be blinded to each other's measurements to maintain objectivity.
- Conditions
- Spinal Column, Lumbar Puncture, Ultrasonography, Position
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
Comparison of Sagittal and Paramedian Oblique Planes for Ultrasound Measurement of Intervertebral Space
The secondary outcome measure was comparison of the sagittal and long-axis paramedian oblique planes in determining the intervertebral space measured by ultrasound in participants whose body mass index was greater than 30.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Apr 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spinal ColumnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emre Sanci, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315451
- Sponsor's protocol ID
- 2021-120
- Status last verified
- Dec 2025
- First submitted
- 2 Mar 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
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.
PubMed 17901137Ferre 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.
PubMed 17349903Stiffler 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.
PubMed 17349909Huang 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.
PubMed 18926360Furness 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.
PubMed 11892638Shi 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.
PubMed 34465511Andreas 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lateral Decubitus and Upright Sitting Positions in Measuring Intervertebral Space Via Ultrasound in Obese Volunteers
- ClinicalTrials.gov ID
- NCT07315451
- Acronym / sponsor ID
- 2021-120
- Conditions
- Spinal Column, Lumbar Puncture, Ultrasonography, Position
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted in the Emergency Medicine Clinic of University of Health Sciences Kocaeli City Hospital. Participants over the age of 18 with a body mass index (BMI) of 30 or higher presenting to the emergency department will be included. After providing verbal information about the study, written informed consent will be obtained from participants who agree to take part. Participants will be evaluated by attending physicians in the emergency department, who will then inform the study investigators.
The upright sitting position is defined as the patient sitting upright on the stretcher with their legs hanging down the side, feet not touching the ground, and arms extended forward for support. The lateral decubitus position is defined as the patient lying on their side with their shoulders and hips perpendicular to the stretcher, knees flexed, and pulled toward the chest.
The ultrasound applications will be performed by two study investigators: one emergency medicine specialist with advanced ultrasound training and one with basic ultrasound training. Measurements will be taken first in the participant's preferred position (upright sitting or lateral decubitus) and then in the alternate position.
Since the traditional method for identifying the lumbar puncture (LP) site-known as Tuffier's line (the midpoint of the line connecting both anterior superior iliac spines in the lumbar region)-can be misleading in obese patients, the application site will be determined via ultrasound. An Esaote MyLab™ Gamma ultrasound device will be used, with the Esaote SL1543 linear probe as the first choice. If the linear probe does not provide adequate depth due to obesity, the Esaote SP2730 curved probe will be used.
For ultrasound application, the probe will initially be placed transversely just above the intragluteal fold, with the indicator pointing to the patient's left shoulder. Once the midline is identified, measurements will be performed in two planes: sagittal and long-axis paramedian oblique.
For the sagittal plane, the probe will be rotated 90 degrees with the indicator pointing toward the patient's head.
For the long-axis paramedian oblique plane, the probe will also be rotated 90 degrees toward the head but moved 1-2 cm laterally from the midline and angled slightly medially.
The probe will then be moved superiorly until the L4-L5 interspinal space is identified. The intervertebral space is defined as the hypoechoic region between hyperechoic spinous processes. Measurements will be taken from the L4-L5 and L3-L4 intervertebral spaces.
Each practitioner's measurements will include the distance to the ligamentum flavum, as well as data on whether the patient has undergone lumbar surgery, and their weight and height. These will be recorded in a pre-prepared standard data form. Practitioners will be blinded to each other's measurements to maintain objectivity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers who want to participate in the study will be included.
Key inclusion criteria (2 listed)
- participants whose body mass index was greater than 30
- participants older than eighteen years old.
Key exclusion criteria (3 listed)
- participants who have a history of lumbar surgery
- participants who have an infection on the lombar region
- pregnant volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Lateral Decubitus and Upright Sitting Positions in Ultrasound Measurement of Intervertebral Space in Adults with a BMI Over 30
Time frame: Baseline
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
1 secondary outcome
Comparison of Sagittal and Paramedian Oblique Planes for Ultrasound Measurement of Intervertebral Space
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- BackgroundRoberts 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: PubMed 17901137Nomura 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.
- Background: PubMed 17349903Ferre 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.
- Background: PubMed 17349909Stiffler 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.
- Background: PubMed 18926360Huang 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.
- Background: PubMed 11892638Furness 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.
- Background: PubMed 34465511Shi 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.
- BackgroundAndreas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Column and Lumbar Puncture, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 2 Jan 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Comparison of Lateral Decubitus and Upright Sitting Positions in Ultrasound Measurement of Intervertebral Space in Adults with a BMI Over 30 (time frame: Baseline). 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 NCT07315451, which also lists 8 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 2 Jan 2026.