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临床试验/NCT03090295
NCT03090295已完成不适用

Does the Use of Both Palpation and Accuro as Compared to Palpation Alone or Use of Accuro Alone in a Single Patient Increase the First Pass Success Rate in Placing Spinals or Combined Spinal Epidurals for Cesarean Sections.

University of Virginia1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年3月13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
80
试验地点
1
主要终点
success rates

研究概览

简要总结

The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures.

We aim to assess the benefit of using both the Accuro and traditional landmark palpation technique to determine accurate spinal level in women who undergo cesarean section. This study will also assess provider preference for use of both Accuro and palpation compared with palpation alone or use of Accuro alone.

Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace.

Results will be compared to results obtained in IRB 18070 "Handheld 3D lumbar spine navigation: A clinical validation study RM002" where subjects who were undergoing a C-section were randomized to either palpation or Accuro alone.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •• Patients between the ages of 18 and 45 presenting for a C-section delivery or scheduled for elective Cesarean section
  • •ASA-1, ASA-2, and ASA-3
  • •Patients with no known back deformities
  • •Ability to sit upright for spinal placement
  • •No prior lumbar surgery
  • •No allergies to ultrasound gel

排除标准

  • •• Unable or unwilling to give informed consent

研究组 & 干预措施

Palpation and Accuro

Experimental

The placement site for the spinal anesthesia will be identified using both palpation and Accuro.

干预措施: Palpation and Accuro (Device)

结局指标

主要结局

success rates

时间窗: Day 1

Success rates: defined as successful spinal administration on the first needle insertion attempt.

次要结局

  • Level of spinal placement: a record of the vertebral level where the spinal is administered.(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Tiouririne, MD

Associate Professor

University of Virginia

研究点 (1)

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