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临床试验/NCT03428113
NCT03428113已完成不适用

Measuring Bladder Volumes With Ultrasound and Bladder Scanning in the ICU

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Intermittent Straight Catheterization Volume Compared to Point of Care Ultrasound Measurement Volume

研究概览

简要总结

ICU patients are at risk for catheter associated urinary tract infection. Frequently patients can't tell clinicians if they need to void if the catheter is removed. If clinicians know that an accurate volume measurement s of urine volume in the bladder can be obtained when the catheter is removed, catheters could be removed earlier and more frequently and thus possibly avoid an infection. For this study, measures with ultrasound (directly visualizing the bladder to measure), bladder scanner (partially blind measure with placement of scanner over the expected bladder location on the skin) and urine catheterized volume will be obtained. The investigators also want to know if the technology is user dependent. The study will include 2 levels of nurses RN and advanced practice RN (APRN) perform the bladder scanner. An APRN and MD will conduct the ultrasound. Ultrasound is technology primarily used by physicians but APRNs are using the technology technology more frequently. After these 4 measurements, the patient's nurse will perform an intermittent straight catheterization (catheter inserted, urine drained, and catheter removed) as the gold standard comparison.

详细描述

The purpose of this correlational descriptive study is to compare measured bladder volumes with a bladder scanner (Verathon Prime), 3D ultrasound (Sono-Site II) and straight catheterization in ICU patients with low urine output receiving dialysis and in ICU patients unable to void.

Upon consent of patient or LAR, patient's age, gender and BMI with the assigned study code number will be recorded on enrollment log. Study code number, patient initials and unit will be written on bedside data collection sheet.

Sequence of 4 non-invasive (1-4) measurement will vary from day to day (see below)

  1. MD performs bladder ultrasound and records volume on data collection sheet and places in envelope
  2. APRN performs bladder scanner and records volume on data collection sheet and places in envelope.
  3. APRN performs bladder ultrasound and records volume on data collection sheet and places in envelope
  4. Bedside RN performs bladder scanner and records volume on data collection sheet and places in envelope
  5. The study team will record the data from the straight catheterization that is performed as part of clinical care.
  6. APRN or research nurse will retrieve catheterization urine volume measurement from RN or from chart and record on data collection sheet

Each enrolled patient will have these 4 measurements performed only on one day. Each clinician research team member will record their result on a data collection form with the study number, patient initials, day of week, clinician initials, observation of abdominal fluid, and comment section for any other observations. The clinician research team member will place the completed form for their measurement in an envelope with the study number on the outside while the next clinician is in the room obtaining the next measure.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ICU dialysis patients who have their catheter removed per ICU medical team
  • ICU patients without an indwelling urinary catheter and inability to void 6 hours post urinary catheter removal or 6 hours after admission

排除标准

  • Pregnant women Prisoners

结局指标

主要结局

Intermittent Straight Catheterization Volume Compared to Point of Care Ultrasound Measurement Volume

时间窗: At time of enrollment, one point in time

Comparison of the two measurements of bladder volume will be analyzed

Intermittent Straight Catheterization Volume Compared to Bladder Scan Measurement Volume

时间窗: At time of enrollment, one point in time

Comparison of the two measurements of bladder volume will be analyzed

次要结局

  • Clinician Level Measurements with Bladder Scanner and Point of Care Ultrasound(At time of enrollment, one point in time)

研究者

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

Lynn Schallom

Director of Research For Patient Care Services at Barnes-Jewish Hospital

Washington University School of Medicine

研究点 (1)

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