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

This study is currently recruiting participants.
Verified December 2015 by Brennan Spiegel, Cedars-Sinai Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02065583
First Posted: February 19, 2014
Last Update Posted: December 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Brennan Spiegel, Cedars-Sinai Medical Center
  Purpose
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
Post Operative Ileus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Validity of a Computer-Aided, Non-Invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Post-Operative Feeding

Further study details as provided by Brennan Spiegel, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
GI abdominal surgery patients
Patients recovering from gastrointestinal abdominal surgery.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)
  Contacts and Locations
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
  More Information

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 Submitted: December 20, 2013
First Posted: February 19, 2014
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