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临床试验/NCT03927755
NCT03927755已完成不适用

REASON 2 Trial - Timing For Single View Bedside Cardiac Ultrasound

University of Massachusetts, Worcester1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年6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
5,000
试验地点
1
主要终点
Timing of Ultrasound Imaging

研究概览

简要总结

The goal of this study is to measure the hypothetical minimal amount of time it takes to perform a single view bedside trans-thoracic echo (TTE) comparing sub-xyphoid view and the parasternal long view. Physicians will be timed from initiation of imaging to completion of the recording of a single view of the heart. Images will be rated for quality.

详细描述

This is a multi-center, prospective, observational trial involving sites across the United States and Canada. Residents will be enrolled when performing ultrasound imaging on non-critically ill patients in the emergency department. Residents obtaining cardiac ultrasound images on patients in the emergency department during pre-planned educational sessions will be enrolled in a prospective manner.

Physicians participating in this study will undergo a short educational session on both techniques of cardiac ultrasound as well as rationale for performing cardiac ultrasound rapidly during cardiac arrest. This educational intervention will provide the cognitive framework for the physicians to participate in the study. Physicians will be told to obtain the images as fast as possible and to get good quality images but they will be able to stop imaging if they are unable to obtain the images rapidly.

Individual physicians will be randomized to obtain a single parasternal or sub-xyphoid view of the hear first, followed by the other view. TTE will be performed on conscious and awake patients in the emergency department. Imaging will be performed in front of research staff. Primary outcome is time from transducer-skin contact to completion of the digital recording of a visible heart beating. Secondary outcome is the quality of the ultrasound image using a 5-point image quality scale.

Patients who will be imaged in this study will be those patients that would have been imaged during the existing educational session (scan shift). The patient will not need consent but can be told about the study if needed. No patient will be imaged if they have the possibility of having a clinical deterioration during the ultrasound imaging. Each set of images (PSL and SX) will be from a unique patient.

Subject data, with Protected Health Information (PHI) removed, will be recorded on data sheets prior to uploading into a centralized electronic database as soon as possible. Data will be obtained during the educational encounter including: Resident ID, post graduate year (PGY) level, Number of Cardiac Ultrasounds performed prior to starting study, US view attempted first, Imaging duration (seconds), Patient height, weight gender and age.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Physicians with experience in bedside cardiac ultrasound

排除标准

  • Unwilling to consent to study
  • Appropriate ultrasound equipment not available

结局指标

主要结局

Timing of Ultrasound Imaging

时间窗: 10 seconds

Number of seconds from start to finish of the ultrasound imaging

次要结局

  • Quality of Ultrasound Imaging(5 seconds)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Romolo Gaspari

Professor, Department of Emergency Medicine

University of Massachusetts, Worcester

研究点 (1)

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