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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by VA Greater Los Angeles Healthcare System
Sponsor:
Collaborator:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Brennan Spiegel, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT02065583
First received: December 20, 2013
Last updated: September 18, 2014
Last verified: September 2014
  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 VA Greater Los Angeles Healthcare System:

Primary Outcome Measures:
  • Count of motility events per minute. [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 20, 2013
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by VA Greater Los Angeles Healthcare System:
Ileus
Equipment and Supplies
Technology
Acoustics

ClinicalTrials.gov processed this record on October 23, 2014