Clinical trial NCT02396446: AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score
Official title: AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fasting
Diet
Biosensing Techniques
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients at CSMC

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of acoustic events
timeFrame: One minute
measure: Mean time to advancement to full diet
timeFrame: Inpatient visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Brennan Spiegel, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
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