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临床试验/NCT07315451
NCT07315451Enrolling By Invitation不适用

Comparison of Lateral Decubitus and Upright Sitting Positions in Measuring Intervertebral Space Via Ultrasound in Obese Volunteers

Kocaeli City Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
54
试验地点
1
主要终点
Comparison of Lateral Decubitus and Upright Sitting Positions in Ultrasound Measurement of Intervertebral Space in Adults with a BMI Over 30

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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

次要结局

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

研究者

发起方
Kocaeli City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Emre Sanci

M.D., Asst. Prof.

Kocaeli City Hospital

研究点 (1)

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