FastingNCT02396446
AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score
An observational study of Fasting and Diet, run by Cedars-Sinai Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fasting, Diet, Biosensing Techniques
- What is being tested?
- Abdominal acoustic measurement
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inpatients at CSMC
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
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.
Read the 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
- Conditions
- Fasting, Diet, Biosensing Techniques
- Being tested
- Abdominal acoustic measurement
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal acoustic measurementOther
Device meant to listen to the sounds of the gut to determine post op ileus.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Inpatients at CSMC whose abdominal acoustic sounds will be measured using the AbStats device. Receives: Other: Abdominal acoustic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acoustic events
Number of acoustic events recorded by the AbStats device in one minute.
Measured: One minute
Mean time to advancement to full diet
Mean time to advance a patient to a full diet
Measured: Inpatient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJun 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: This study was never completed because the company was not able to support the trial with devices.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brennan Spiegel, Cedars-Sinai Medical Center
- Investigators
- Brennan Spiegel, MD, MSHS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396446
- Sponsor's protocol ID
- Pro00039256
- Status last verified
- Jan 2020
- First submitted
- 18 Mar 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Agarwal E, Ferguson M, Banks M, Batterham M, Bauer J, Capra S, Isenring E. Nutrition care practices in hospital wards: results from the Nutrition Care Day Survey 2010. Clin Nutr. 2012 Dec;31(6):995-1001. doi: 10.1016/j.clnu.2012.05.014. Epub 2012 Jun 18.
PubMed 22717261Barr J, Hecht M, Flavin KE, Khorana A, Gould MK. Outcomes in critically ill patients before and after the implementation of an evidence-based nutritional management protocol. Chest. 2004 Apr;125(4):1446-57. doi: 10.1378/chest.125.4.1446.
PubMed 15078758Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux R N MC, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr. 2005 Aug;24(4):502-9. doi: 10.1016/j.clnu.2005.03.006.
PubMed 15899538Franklin GA, McClave SA, Hurt RT, Lowen CC, Stout AE, Stogner LL, Priest NL, Haffner ME, Deibel KR, Bose DL, Blandford BS, Hermann T, Anderson ME. Physician-delivered malnutrition: why do patients receive nothing by mouth or a clear liquid diet in a university hospital setting? JPEN J Parenter Enteral Nutr. 2011 May;35(3):337-42. doi: 10.1177/0148607110374060. Epub 2011 Mar 7.
PubMed 21383319McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.
PubMed 19398613Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.
PubMed 25091837
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score
- ClinicalTrials.gov ID
- NCT02396446
- Acronym / sponsor ID
- Pro00039256
- Conditions
- Fasting, Diet, Biosensing Techniques
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study was never completed because the company was not able to support the trial with devices.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: Abdominal acoustic measurementInpatients at CSMC whose abdominal acoustic sounds will be measured using the AbStats device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients at CSMC
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal acoustic measurementDevice meant to listen to the sounds of the gut to determine post op ileus. | Other | Intervention group |
Primary outcome
Number of acoustic events
Time frame: One minute
Number of acoustic events recorded by the AbStats device in one minute.
Mean time to advancement to full diet
Time frame: Inpatient visit
Mean time to advance a patient to a full diet
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 22717261Agarwal E, Ferguson M, Banks M, Batterham M, Bauer J, Capra S, Isenring E. Nutrition care practices in hospital wards: results from the Nutrition Care Day Survey 2010. Clin Nutr. 2012 Dec;31(6):995-1001. doi: 10.1016/j.clnu.2012.05.014. Epub 2012 Jun 18.
- Background: PubMed 15078758Barr J, Hecht M, Flavin KE, Khorana A, Gould MK. Outcomes in critically ill patients before and after the implementation of an evidence-based nutritional management protocol. Chest. 2004 Apr;125(4):1446-57. doi: 10.1378/chest.125.4.1446.
- Background: PubMed 15899538Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux R N MC, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr. 2005 Aug;24(4):502-9. doi: 10.1016/j.clnu.2005.03.006.
- Background: PubMed 21383319Franklin GA, McClave SA, Hurt RT, Lowen CC, Stout AE, Stogner LL, Priest NL, Haffner ME, Deibel KR, Bose DL, Blandford BS, Hermann T, Anderson ME. Physician-delivered malnutrition: why do patients receive nothing by mouth or a clear liquid diet in a university hospital setting? JPEN J Parenter Enteral Nutr. 2011 May;35(3):337-42. doi: 10.1177/0148607110374060. Epub 2011 Mar 7.
- Background: PubMed 19398613McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.
- Background: PubMed 25091837Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brennan Spiegel, MD, MSHS principal investigator
Cedars-Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting and Diet, run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acoustic events (time frame: One minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396446, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.