Abstats: Computer-aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Acute Pancreatitis
NCT ID: NCT02412826
Last Updated: 2016-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2015-04-30
2017-04-30
Brief Summary
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Detailed Description
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The AbStats multi-sensor wireless abdominal monitoring system includes low profile acoustic sensors that are applied to the anterior abdominal wall with Tegaderm and monitors sounds emanating from the GI tract. The acoustic sensors continuously and non-invasively monitor and capture audio signals representing GI and abdominal wall function. The captured data is recorded in a synchronized manner from all sensors.
We will place the AbStats sensor on all patients immediately after admission to the hospital. Only study staff trained on the AbStats system will apply the sensors, which fit externally around the abdomen. A physician member of our study staff will be available at all times to help position the device if needed. We will continuously record AbStats acoustic signals for the duration of the hospitalization, with the option to discontinue as clinically required or requested by the provider or patient. A research coordinator will collect clinical data from medical records and enter the data into a secure spreadsheet on CSMC servers. Patients will be asked to keep a daily diary of symptoms. In this diary, the patients will be asked to record information about their food consumption (if any), bowel movements (if any and if associated with contrast from CT imaging or with the use of suppositories/ laxative), specific symptoms, and whether the sensor was removed for any period of time during the day. This will allow us to compare the data collected by the AbStats sensor with self-reported symptoms noted by patients. Physicians and nurses will not be made aware of the AbStats readings so as to eliminate the Hawthorne effect. Patients will be managed according to standard-of-care practice and the data collected by the AbStats device will not be incorporated into clinical care.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Acute pancreatitis
Patients presenting to the hospital with acute pancreatitis that will receive AbStats sensor
Abstats sensor
The AbStats abdominal biosensor will be applied to the abdomen of patients who are admitted with acute pancreatitis.
Interventions
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Abstats sensor
The AbStats abdominal biosensor will be applied to the abdomen of patients who are admitted with acute pancreatitis.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of acute pancreatitis; must meet at least 2 out of the 3 following critiera:
1. abdominal pain consistent with acute pancreatitis
2. serum amylase/lipase \>3 times upper limit of normal
3. characteristic findings from abdominal imaging
* able to provide informed consent
Exclusion Criteria
* transfer patients
* cognitive inability to follow directions to maintain sensors in place
* unable to place abdominal sensors on patients
* abdominal cellulitis
* pregnant women
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Elham Afghani
Assistant Director, Clinical Pancreatology
Principal Investigators
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Elham Afghani, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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References
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Negro P, D'Amore L, Saputelli A, Talarico C, Scaccia M, Tuscano D, Gossetti F, Carboni M. Colonic lesions in pancreatitis. Ann Ital Chir. 1995 Mar-Apr;66(2):223-31.
Abcarian H, Eftaiha M, Kraft AR, Nyhus LM. Colonic complications of acute pancreatitis. Arch Surg. 1979 Sep;114(9):995-1001. doi: 10.1001/archsurg.1979.01370330017003.
Russell JC, Welch JP, Clark DG. Colonic complications of acute pancreatitis and pancreatic abscess. Am J Surg. 1983 Nov;146(5):558-64. doi: 10.1016/0002-9610(83)90288-x.
Shi LL, Liu MD, Chen M, Zou XP. Involvement of interstitial cells of Cajal in experimental severe acute pancreatitis in rats. World J Gastroenterol. 2013;19(14):2179-86. doi: 10.3748/wjg.v19.i14.2179.
Leveau P, Wang X, Soltesz V, Ihse I, Andersson R. Alterations in intestinal motility and microflora in experimental acute pancreatitis. Int J Pancreatol. 1996 Oct;20(2):119-25. doi: 10.1007/BF02825510.
Seerden TC, De Man JG, Holzer P, Van den Bossche RM, Herman AG, Pelckmans PA, De Winter BY. Experimental pancreatitis disturbs gastrointestinal and colonic motility in mice: effect of the prokinetic agent tegaserod. Neurogastroenterol Motil. 2007 Oct;19(10):856-64. doi: 10.1111/j.1365-2982.2007.00968.x.
Wang X, Gong Z, Wu K, Wang B, Yuang Y. Gastrointestinal dysmotility in patients with acute pancreatitis. J Gastroenterol Hepatol. 2003 Jan;18(1):57-62. doi: 10.1046/j.1440-1746.2003.02898.x.
Davis S, Parbhoo SP, Gibson MJ. The plain abdominal radiograph in acute pancreatitis. Clin Radiol. 1980 Jan;31(1):87-93. doi: 10.1016/s0009-9260(80)80088-2.
Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.
Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
Yadav D, Lee E, Papachristou GI, O'Connell M. A population-based evaluation of readmissions after first hospitalization for acute pancreatitis. Pancreas. 2014 May;43(4):630-7. doi: 10.1097/MPA.0000000000000078.
Vipperla K, Papachristou GI, Easler J, Muddana V, Slivka A, Whitcomb DC, Yadav D. Risk of and factors associated with readmission after a sentinel attack of acute pancreatitis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1911-9. doi: 10.1016/j.cgh.2014.04.035. Epub 2014 May 9.
Tomomasa T, Morikawa A, Sandler RH, Mansy HA, Koneko H, Masahiko T, Hyman PE, Itoh Z. Gastrointestinal sounds and migrating motor complex in fasted humans. Am J Gastroenterol. 1999 Feb;94(2):374-81. doi: 10.1111/j.1572-0241.1999.00862.x.
Augustyniak P. Wearable wireless heart rate monitor for continuous long-term variability studies. J Electrocardiol. 2011 Mar-Apr;44(2):195-200. doi: 10.1016/j.jelectrocard.2010.11.014.
Shambroom JR, Fabregas SE, Johnstone J. Validation of an automated wireless system to monitor sleep in healthy adults. J Sleep Res. 2012 Apr;21(2):221-30. doi: 10.1111/j.1365-2869.2011.00944.x. Epub 2011 Aug 22.
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.
Other Identifiers
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Pro00038455
Identifier Type: -
Identifier Source: org_study_id
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