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临床试验/NCT03135379
NCT03135379已完成不适用

Comparison of Patient Satisfaction Using Heated Versus Room Temperature Ultrasound Gel: a Single-blind Randomized Controlled Trial

Brooke Army Medical Center0 个研究点目标入组 124 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
主要终点
Patient Satisfaction

研究概览

简要总结

The purpose of this single-blind, randomized control trial will be to investigate whether simply having warmed gel, as compared to room-temperature gel, during a bedside ultrasound significantly improves patient satisfaction scores.

详细描述

ED physicians who identify that a patient will require an ultrasound will page the ultrasound team as part of standard of care. At that time, an investigator will obtain verbal consent from the patient and provide an information sheet to help explain study details/answer any questions. The patient will then be randomized to either warmed gel or room temperature gel. Investigators will handle the gel using a heat-resistant glove (ULine Terry Cloth Glove) to maintain blinding to the gel temperature. A bedside ultrasound study will then be performed by emergency physicians not otherwise involved in the study using the study gel. Immediately upon ultrasound completion, the patients will complete a satisfaction survey. The images from the study will be saved and subsequently reviewed by an emergency physician with fellowship training in ultrasound to score image quality from 1 (low) to 5 (high).

研究设计

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

盲法说明

A heat-resistant glove, ULine Terry Cloth Glove (Appendix F), will be used by the investigators to handle the ultrasound gels.

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-89 years
  • Patients require bedside ultrasound

排除标准

  • Patients under age 18
  • Patients over age 89
  • Pregnant women
  • Altered mental status
  • Incarcerated
  • Military basic trainees
  • Primary language other than English
  • Patients with open or broken skin over areas requiring ultrasound gel application

结局指标

主要结局

Patient Satisfaction

时间窗: Immediately upon completion of ultrasound examination

Measured on 100-mm visual analogue scale. This scale is a horizontal line on a sheet of paper measuring 100 mm. The scale ranges from 0 on the left (representing "completely unsatisfied") to 100 on the right (representing "completely satisfied"). We instructed subjects to draw a single vertical mark through the horizontal line to represent how satisfied they were with their overall emergency department visit.

次要结局

  • Ultrasound Image Quality(Within 1 week of completion of ultrasound examination)

研究者

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

Michael D. April

Assistant Program Director for Research, Emergency Medicine

Brooke Army Medical Center

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