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Predictive Validity of Acoustic Gastrointestinal Surveillance (AGIS) in Post-Operative Feeding (AGIS)

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ClinicalTrials.gov Identifier: NCT02065583
Recruitment Status : Unknown
Verified December 2015 by Brennan Spiegel, Cedars-Sinai Medical Center.
Recruitment status was:  Recruiting
First Posted : February 19, 2014
Last Update Posted : December 11, 2015
Sponsor:
Collaborator:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Brennan Spiegel, Cedars-Sinai Medical Center

Brief Summary:
This study will measure the accuracy of a disposable, non-invasive device for the continuous monitoring of abdominal sounds, called the AGIS sensor (Acoustic Gastro-Intestinal Surveillance) in predicting patients' intolerance to feeding (defined as severe nausea, vomiting, or need to place a nasogastric tube within 4 hours of initiating a standard feeding protocol) following abdominal surgery. This will be a pragmatic, observational study.

Condition or disease
Post Operative Ileus

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Validity of a Computer-Aided, Non-Invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Post-Operative Feeding
Study Start Date : December 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Group/Cohort
GI abdominal surgery patients
Patients recovering from gastrointestinal abdominal surgery.



Primary Outcome Measures :
  1. Count of motility events per minute. [ Time Frame: 1 minute ]
    The primary unit of analysis will be the number of motility events registered by the AGIS sensor per minute.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators will recruit patients who are scheduled for GI abdominal surgery at Cedars-Sinai Medical Center
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Patient scheduled to undergo abdominal surgery

Exclusion Criteria:

  1. Cannot consent or has no surrogate who can consent.
  2. Cognitive inability to follow directions to maintain abdominal device in place
  3. Any abdominal wall condition that disallows topical coverage as deemed by the managing surgeons (e.g. open abdominal wound, oozing wound, advanced cellulitis, necrotizing fasciitis, etc)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065583


Contacts
Contact: Jennifer Talley, MSPH 310-423-0508 Jennifer.Soares@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Brennan MR Spiegel, MD, MSHS    310-423-6467    brennan.spiegel@cshs.org   
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Brennan Spiegel, MD, MSHS Cedars-Sinai Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brennan Spiegel, Director, Health Services Research, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02065583     History of Changes
Other Study ID Numbers: Spiegel 0016
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by Brennan Spiegel, Cedars-Sinai Medical Center:
Ileus
Equipment and Supplies
Technology
Acoustics