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

NCT02396446 | Withdrawn

• 1 other identifier: Pro00039256
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fasting; Diet; Biosensing Techniques

Outcome Measures

Primary Outcomes (2)

• Number of acoustic events

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

  One minute

• Mean time to advancement to full diet

  Mean time to advance a patient to a full diet

  Inpatient visit

Study Arms (1)

Intervention group

Inpatients at CSMC whose abdominal acoustic sounds will be measured using the AbStats device.

Other: Abdominal acoustic measurement

Interventions

Abdominal acoustic measurement OTHER

Device meant to listen to the sounds of the gut to determine post op ileus.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients at CSMC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Related Publications (6)

• 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.

  PMID: 22717261 BACKGROUND

• Barr 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.

  PMID: 15078758 BACKGROUND

• Villet 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.

  PMID: 15899538 BACKGROUND

• Franklin 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.

  PMID: 21383319 BACKGROUND

• McClave 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.

  PMID: 19398613 BACKGROUND

• Spiegel 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.

  PMID: 25091837 BACKGROUND

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Brennan Spiegel, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Health Services Research

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: June 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01