Fasting Clinical Trial
Official title:
AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score
NCT number | NCT02396446 |
Other study ID # | Pro00039256 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | June 2017 |
Est. completion date | December 2018 |
Verified date | January 2020 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of acoustic events | Number of acoustic events recorded by the AbStats device in one minute. | One minute | |
Primary | Mean time to advancement to full diet | Mean time to advance a patient to a full diet | Inpatient visit |
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