跳至主要内容
临床试验/NCT02396446
NCT02396446撤回不适用

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

Cedars-Sinai Medical Center0 个研究点开始时间: 2017年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Mean time to advancement to full diet

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • 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

排除标准

  • 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

结局指标

主要结局

Mean time to advancement to full diet

时间窗: Inpatient visit

Mean time to advance a patient to a full diet

Number of acoustic events

时间窗: One minute

Number of acoustic events recorded by the AbStats device in one minute.

次要结局

未报告次要终点

研究者

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

Brennan Spiegel

Director of Health Services Research

Cedars-Sinai Medical Center

相似试验