Ultrasound Evaluation Of Two Anatomic Landmarks In Spinal Anesthesia For Cesarean Section: The Posterior Superior Iliac Spine vs Iliac Crest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- The distance between the PSIS line and each mid-interspinous space
研究概览
简要总结
Intercristal line as palpation landmarks to identifying the vertebral level is frequently inaccurate.To find more safe and reliable body surface markers and convenient methods to be solved in clinical work.The investigators performed a two-stage study to evaluated the accuracy of intercristal line and the The Posterior Superior Iliac Spine (PSIS) line to identify the lumbar interspinous spaces for spinal anesthesia using ultrasonography in pregnant woman which will provide a second option.
详细描述
The investigators performed a two-stage study to evaluated the accuracy of Intercristal line and the PSIS line to identify the lumbar intervertebral space for spinal anesthesia using ultrasonography in pregnant woman. In phase 1, the distances between the PSIS line and each lumbar interspinous space is measured by ultrasound,and the mean and 95% confidence interval of distances in pregnant women with different height ranges were calculated to provide a reference for identifying specific lumbar spaces.In phase 2, a further 230 participants were received the PSIS, Intercristal line or both as palpation landmarks to define specific lumbar spaces.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •After obtaining written informed consents,pregnant women at 37-42 weeks of gestation
排除标准
- •BMI ≥ 40 kg/m² (to minimize palpation variability), History of lumbar surgery/deformity (scoliosis, spondylolisthesis or osteoporotic vertebral collapse), Inability to maintain the flexed lateral decubitus position, Participant withdrawal, Unforeseen anatomical anomalies discovered during screening.
研究组 & 干预措施
Group M
Based on an interim analysis of Phase 1 data, we established the following decision protocol for L3/4 interspinous space localization:
- PI ≥9 cm: Select the interspace at or immediately below the PI line.
- PI ≤7 cm: Select the interspace at or immediately above the PI line.
- PI 7-9 cm: Apply a 6.5-10 cm target window from the PSIS point.
- If one interspace lies within this window, select it.
- If multiple interspaces are present, choose the most caudal one.
T group
The intercristal line-based palpation protocol followed the rule described by Kim et al[19], with minor modifications to accommodate the flexed lateral decubitus position: Select the interspinous space that is either intersected by the intercristal line or lies immediately below it.
P group
The PSIS line-based palpation protocol stipulated targeting the L3/4 interspinous space within the an interval using hierarchical rules: single spaces are labeled L3/4; for two spaces, L3/4 is the intercristal line-intersected one (or lower if neither); for rare three spaces, the lowest is L3/4
结局指标
主要结局
The distance between the PSIS line and each mid-interspinous space
时间窗: three days
PSIS line was defined as an intercristal line drawn between the the final posterior superior iliac spine point.Use a ruler to measure the distance between the PSIS line and each midddle- interspinous space （L1/2 through L5/S1）and record. The mean of distances and 95% confidence interval are calculated.
The accuracy of the anatomic landmarks to determine the L3/4 interspinous space
时间窗: three days
The L3-L4 intervertebral space was detected using intercristal line and the PSIS line in a random order by 2 experienced anesthesiologists. After determining the L3-L4 intervertebral space using each method alternately, horizontal skin marks were created with an erasable pen. Then, another experienced anesthesiologist for ultrasonographic examination assessed the intervertebral spaces.After identifying the sacrum, the investigator moved the probe in a cephalad direction, counted the intervertebral spaces and assessed the actual intervertebral spaces of the 2 skin marks.
次要结局
- baseline data(three days)
- The distance between the palpated intercristal line and PSIS line(three days)
- Maternal height(three days)