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临床试验/NCT03719872
NCT03719872已完成不适用

Utility of Bedside Ultrasound for Diagnosis of Intraperitoneal Free Air

David Blehar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Presence of Free Air Artifact on Ultrasound

研究概览

简要总结

This study evaluates the ability of ultrasound to identify intraperitoneal free air. The study will consist of blinded review of abdominal ultrasound images of patients before and after laparoscopic surgery, a procedure which results in the introduction of air into the peritoneal cavity.

详细描述

Free peritoneal air is a marker of potential intraabdominal catastrophe, reflecting perforation of a hollow viscous organ such as stomach or intestine. While definitively identified by computed tomography, this diagnostic test can be delayed. Presence of air beneath the diaphragm on an upright chest or abdominal radiograph can allow for faster diagnosis, but again can present limitations in terms of timing.

Bedside clinician performed ultrasound has become standard practice in emergency medicine and critical care settings. Traditionally, air is not conducive to diagnostic ultrasound, but the artifacts it creates can be used to give clues about certain conditions. Recently this artifact has been proposed as a means to identify free peritoneal air. Several small studies have shown promise for the technique, but further investigation is warranted.

In this study the investigators will generate a database of standardized abdominal ultrasound images in subjects undergoing laparoscopic surgery. During this surgery, the peritoneal cavity is intentionally insufflated with air. The majority of this is removed at the end of the case, but small volumes of air remain, as evidence by the presence of air on CT scan when performed shortly after surgery.

The investigators will obtain a standardized set of images preoperatively and post operatively which will then be reviewed in a blinded fashion by three expert reviewers, one each from radiology, surgery and emergency medicine, with data analysis to determine sensitivity and specificity of ultrasound for free air.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Subjects scheduled for elective laparoscopic surgery
  • Age 18 or greater

排除标准

  • Age less than 18
  • unable to provide consent

结局指标

主要结局

Presence of Free Air Artifact on Ultrasound

时间窗: Following completion of laparoscopic surgery, average of 2 hours, up to 1 day.

Hyperechoic echo originating from peritoneal stripe

次要结局

未报告次要终点

研究者

发起方
David Blehar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Blehar

Associate Professor of Emergency Medicine

University of Massachusetts, Worcester

研究点 (1)

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