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AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score

2020年1月23日 更新者:Brennan Spiegel、Cedars-Sinai Medical Center

This study is being conducted to determine whether providers who have access to their patients' acoustic intestinal rate score as calculated by an abdominal acoustic sensor that continuously monitors bowel sounds (AbStats) will be more likely to advance their patients' diets to a solid diet sooner than those who do not have access to this rate. AbStats calculates intestinal rates by using two small sensors placed on a patient's abdomen to measure and analyze their abdominal sounds.

Patients will be asked to wear a sensor every morning for 20 minutes while they are fasting daily during their inpatient visit. The sensor will measure the sounds within their abdomen. This data will be interpreted by the AbStats device, which will provide an intestinal rate measurement based on the sounds recorded by the sensors.

This intestinal rate will be provided to the patient's treating physician together with other vital signs. The doctor, at his/her discretion, may choose to use this information to make decisions about the patient's feeding status.

研究概览

详细说明

The research team will use an abdominal acoustic sensor that continuously monitors bowel sounds (AbStats) to obtain acoustic measurements from 50 Cedars-Sinai Medical Center (CSMC) hospital patients by placing a disposable sensor on their abdomen. The sensor will be connected to a bedside monitor which records the sounds collected by the sensors and interprets them to create an intestinal rate reading, measured as acoustic events per minute. The research team will enter this score into the patient's chart and make it available to the patient's clinician(s), to use at their discretion to make decisions on whether or not to advance their patient's diet based on intestinal rate interpretation guidelines previously developed. The entry will provide a numerical intestinal rate with a brief interpretation of the score as listed below. This will be based on interpretations of the measures provided by the AbStats bedside computer, which have been previously developed in a wider research study.6 The scores will be interpreted using the following criteria:

Fasting intestinal rate score of <3 per minute: Ileus; Consider holding diet advancement until there is more evidence of GI function (feeding "red light")

Fasting intestinal rate score of 3-5 per minute: Slow motility; Consider advancing to liquid diet if NPO, assuming it is otherwise medically and surgically appropriate (feeding "yellow light")

Fasting intestinal rate score of >5 per minute: Normal motility; consider advancing to full diet if medically and surgically appropriate (feeding "green light")

Even though these readings will be provided in the patient chart, physicians must use their clinical judgment and account for mental status, aspiration risk, medications, surgical and medical comorbidities before making any feeding decisions. The intestinal rate is merely a new piece of information that provides objective evidence of GI function; it is likely superior to current best practices, which are notoriously unreliable for truly determining GI functional status and motility.

The research team will discuss the project with the patient's medical teaching attending physician, and will request their approval prior to approaching a patient. Once the doctor's approval is secured, researchers will approach the patient and provide them with detailed information about the project activities. If they agree to participate, the AbStats sensor will be placed on the patient's abdomen every morning for 20 minutes while the patient is fasting for the duration of their hospital stay. The sensor will be connected to a bedside computer that will process the data and calculate an intestinal rate, which will appear on the AbStats' gateway screen. The rate and its time-stamp will be entered into the patient's CS-Link (CSMC's EHR) chart by the research team. Once the patient is discharged, their participation in the study will be completed.

After discharge, the patient's chart will be reviewed by a member of the research staff. Using the "Dietary Orders" section of the "Active Orders" tab of the "Patient Summary" section of the patients CS-Link chart, we will determine the length of time from fasting (NPO) to full diet for each patient, as X1-X0, where X1 is time of order to full diet and X0 is time of hospital admission as noted in the "Encounters" section of the patient chart. Full diet will be determined from a dietary order in the chart stating "Diet Regular". The time to full diet will be reported in hours.

Medical residents and members of the Cedars-Sinai Department of Health Services Research staff will collect the following data (measures) at the patient's bedside:

Patient time (hours) to advancement to solid diet Abdominal intestinal rate measured by AbStats disposable biosensor

研究类型

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Inpatients at CSMC

描述

Inclusion Criteria:

  • Awake and alert
  • Not on a regular diet
  • No mild to moderate acute pancreatitis
  • No obstructed bowel not amenable to feeding tube placement beyond the obstruction
  • No massive GI hemorrhage
  • No impending or established toxic megacolon
  • No colonic perforation
  • No severe dysmotility making enteral feeding not possible
  • No high output intestinal fistula
  • Able to access the gut for enteral feeding
  • No abdominal compartment syndrome
  • No withdrawal of care/DNAR status
  • No evidence of severe or prolonged ileus
  • No hemodynamic compromise (MAP <60) requiring high dose vasopressors alone or in combination with large volume fluid or blood product resuscitation to maintain cellular perfusion
  • No diffuse peritonitis
  • No intractable vomiting
  • Not pregnant
  • At least 18 years of age

Exclusion Criteria:

  • Not awake and alert
  • On regular diet
  • Mild to moderate acute pancreatitis
  • Obstructed bowel not amenable to feeding tube placement beyond the obstruction
  • Massive GI hemorrhage
  • Impending or established toxic megacolon
  • Bowel perforation
  • Severe dysmotility making enteral feeding impossible
  • High output intestinal fistula
  • Unable to access the gut for enteral feeding
  • Abdominal compartment syndrome
  • Withdrawal of care/DNAR status
  • Severe ileus with NG output >1200 ml/d or gastric residual volumes >400 with additional signs of intolerance including absence of bowel sounds, abdominal distention, presence of air/fluid levels on abdominal radiographs
  • Hemodynamic compromise (MAP <60) requiring high dose vasopressors alone or in combination with large volume fluid or blood product resuscitation to maintain cellular perfusion
  • Diffuse peritonitis
  • Intractable vomiting
  • Pregnant women
  • Under 18 years of age

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Intervention group
Inpatients at CSMC whose abdominal acoustic sounds will be measured using the AbStats device.
Device meant to listen to the sounds of the gut to determine post op ileus.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of acoustic events
大体时间:One minute
Number of acoustic events recorded by the AbStats device in one minute.
One minute
Mean time to advancement to full diet
大体时间:Inpatient visit
Mean time to advance a patient to a full diet
Inpatient visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Brennan Spiegel, MD, MSHS、Cedars-Sinai Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2017年6月1日

初级完成 (预期的)

2018年12月1日

研究完成 (预期的)

2018年12月1日

研究注册日期

首次提交

2015年3月18日

首先提交符合 QC 标准的

2015年3月18日

首次发布 (估计)

2015年3月24日

研究记录更新

最后更新发布 (实际的)

2020年1月27日

上次提交的符合 QC 标准的更新

2020年1月23日

最后验证

2020年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro00039256

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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