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临床试验/NCT03520374
NCT03520374招募中不适用

Evaluating the Effectiveness of a Self-instructional Ultrasound Training Program at Teaching Aspiration Risk Assessment Through Gastric Ultrasound

Stanford University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Novice vs Expert Ultrasonographers Gastric Evaluation

研究概览

简要总结

Perioperative aspiration of gastric contents is a rare but serious adverse event. The risk of aspiration can be estimated by perioperative evaluation of stomach contents with ultrasound using a validated technique and scoring system. A lack of knowledge or familiarity is frequently cited by anesthesia providers as a rationale for not performing perioperative ultrasound assessments. The purpose of this study is to determine whether novice ultrasonography users (medical students, undergraduates, or inexperienced anesthesiologists) can be effectively taught a technique to evaluate stomach contents as compared to experts in ultrasonography.

详细描述

This study will be conducted in two arms. For part 1, we will evaluate the efficacy of the self-taught course at producing accurate reads among novice ultrasound users on ideal, cooperative, adult subjects. For part 2, we will evaluate the effectiveness of the course through an identical study that uses clinical pediatric patients as subjects.

Using available literature and established standards for gastric ultrasound, a 15-minute ultrasound training video course will be designed that gives instruction on ultrasound orientation, use, and the antral scoring system of gastric contents. Ten novice ultrasound users will be selected by study personnel on a volunteer basis from a pool of undergraduate students, medical students, and inexperienced anesthesiologists acting as research interns.

For Part 1, 30 healthy adult volunteers with unknown gastric-content status will be recruited to serve as scanning subjects. For Part 2 (which will only begin after successful completion of Part 1), 30 patients will be recruited from pediatric hospital populations undergoing surgery in the preoperative area or the in- patient unit.

Each novice will assess the gastric contents of 6 subjects (3 in Part 1 and 3 in Part 2) using the clinical algorithm for gastric ultrasound and aspiration risk assessment - giving an antral grade for each subject (a score of 0-2). Each novice ultrasound assessment will be video recorded. In the weeks following this evaluation, expert ultrasonographers will observe each video and give their own scores for each subject using the antral grading system.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
2 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must:
  • be between ages of 2-60 years of age
  • have parental consent for children 2-17 years of age, or if the participant is 18 years or older, the participant must sign the ICF for them self as an adult
  • undergoing interventional radiology procedures under general anesthesia or located at an inpatient/outpatient facility at LPCH if they are a pediatric patient
  • must be over 18 years of age if a healthy volunteer

排除标准

  • Patients undergoing emergent surgical procedures
  • BMI greater than 24

结局指标

主要结局

Novice vs Expert Ultrasonographers Gastric Evaluation

时间窗: Novice ultrasonographers: for pediatric patients - after anesthesia induction and before the procedure start, for healthy volunteers - hours following signing the consent form. Expert ultrasonographers: weeks following the initial evaluation by novices.

The gastric evaluation of novice and expert ultrasonographers will be compared based on a 3-point numerical evaluation.

次要结局

  • Time elapsed to reach gastric evaluation(Novice ultrasonographers: for pediatric patients - after anesthesia induction and before the procedure start, for healthy volunteers - hours following signing the consent form. Expert ultrasonographers: weeks following the initial evaluation by novices.)

研究者

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

Chi-Ho Ban Tsui

Principal Investigator

Stanford University

研究点 (2)

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