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临床试验/NCT05983029
NCT05983029已完成不适用

Determination of the Utility of the Intergluteal Cleft as a Landmark for nEuraxial Midline identiFication in obsteTric Patients

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Horizontal distance between intergluteal cleft and neuraxial midline

研究概览

简要总结

Our aim is to investigate whether a novel landmark, the groove between the buttocks or the intergluteal cleft, can facilitate the identification of the neuraxial midline in obstetric patients when compared to ultrasound as the reference standard for the determination of this midline

详细描述

Determine if the intergluteal cleft, when compared to ultrasound as the reference standard, can be used to identify the neuraxial midline in obstetric patients

Difference in horizontal distance between the vertical lines of the intergluteal cleft and the neuraxial midline, the latter measured with ultrasound

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

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

入选标准

  • •18 years of age or older
  • •Gestation of 37 weeks or above

排除标准

  • •Acute or chronic confusional state
  • •Allergy to ultrasound gel
  • •Positive for COVID-19 and/or presence of symptoms consistent with SARS-Cov-2, such as anosmia, cough or fever
  • •History of previous surgery to the spine
  • •Scoliosis
  • •Unable to speak and/or understand English

研究组 & 干预措施

Study Group

Each patient will be requested to adopt a standardised upright position. First, two of the investigators will use a spirit level ruler and ink pen to agree upon and visibly mark the horizontal intercristal line on the back of the patient. Second, investigator B will leave the room, and investigator A will make a vertical mark with an ultraviolet pen denoting the intersection of the inferior aspect of the intergluteal cleft and the horizontal intercristal line. Third, investigator A will then leave the room, and investigator B will return to the room to make a vertical mark with an ink pen representing the intersection of the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line. After these two vertical marks have been made at the level of the intercristal line, the horizontal distance between them will be measured in mm by these same two investigators

干预措施: Intergluteal Cleft (Diagnostic Test)

Study Group

Each patient will be requested to adopt a standardised upright position. First, two of the investigators will use a spirit level ruler and ink pen to agree upon and visibly mark the horizontal intercristal line on the back of the patient. Second, investigator B will leave the room, and investigator A will make a vertical mark with an ultraviolet pen denoting the intersection of the inferior aspect of the intergluteal cleft and the horizontal intercristal line. Third, investigator A will then leave the room, and investigator B will return to the room to make a vertical mark with an ink pen representing the intersection of the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line. After these two vertical marks have been made at the level of the intercristal line, the horizontal distance between them will be measured in mm by these same two investigators

干预措施: Neuraxial Midline (Diagnostic Test)

Study Group

Each patient will be requested to adopt a standardised upright position. First, two of the investigators will use a spirit level ruler and ink pen to agree upon and visibly mark the horizontal intercristal line on the back of the patient. Second, investigator B will leave the room, and investigator A will make a vertical mark with an ultraviolet pen denoting the intersection of the inferior aspect of the intergluteal cleft and the horizontal intercristal line. Third, investigator A will then leave the room, and investigator B will return to the room to make a vertical mark with an ink pen representing the intersection of the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line. After these two vertical marks have been made at the level of the intercristal line, the horizontal distance between them will be measured in mm by these same two investigators

干预措施: Horizontal Distance between Vertical Markings (Diagnostic Test)

结局指标

主要结局

Horizontal distance between intergluteal cleft and neuraxial midline

时间窗: 12 months

One horizontal distance and hence one primary outcome

次要结局

  • Difference in horizontal distance stratified by presence of pregnancy induced hypertension(12 months)
  • Difference in horizontal distance stratified by presence of pre-eclampsia(12 months)
  • Difference in horizontal distance stratified by body mass index(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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