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临床试验/NCT05909085
NCT05909085尚未招募不适用

A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices

Yale University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
2
主要终点
Number of needle passes

研究概览

简要总结

In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.

详细描述

Patient will be approached upon admission to labor and delivery floor (Standard of care). The study will be presented to the patient and if they agree, they will be consented. (Study). Upon epidural patient request patient will be randomized to A-US vs B-US based on the randomization table. Ten envelopes will be available with the randomization choice. (Study). The resident will walk in with both US devices into the room (for patient blinding) and perform scan with the device the randomization table called for. (Study). After performing scan and markings of the patients back, the research fellow or clinical fellow will be called into the room to evaluate the number of needle manipulation and provide surveys related to patient and labor analgesia satisfaction. (Study).

Number of needle insertion attempts: defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt. Time to landmark identification: defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the LT and UST corresponds to when the resident physician first places his/her hand on the patient to palpate the back. In both groups, all materials, supplies, and equipment will be prepared and readily available prior to the start of the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • ASA-1, ASA-2, and ASA-3
  • Patients with no known back deformities
  • Ability to sit upright for epidural placement
  • No prior lumbar surgery
  • No allergies to ultrasound gel

排除标准

  • Coagulopathy
  • Low platelet count
  • Allergies to local anesthetics

结局指标

主要结局

Number of needle passes

时间窗: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes

Number of ventral needle movements without removing needle from skin. A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin.

次要结局

  • Number of Needle attempts(From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes)
  • Time from local anesthetic injection till time of epidural space identification(Up to 60 minutes)
  • Time to obtain ultrasound images with traditional ultrasound device(Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes)
  • Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance(Up to 60 minutes)
  • Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance(Up to 60 minutes)
  • Time to obtain images with automated ultrasound device(Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes)
  • Patient satisfaction(15 - 20 minutes after epidural placement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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