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

Status unconfirmed

Conditions studied: Post Operative Ileus

In brief

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.

Key facts

Study ID

NCT02065583

Run by

VA Greater Los Angeles Healthcare System

People needed

100

Starts

2013-12-01

Expected to finish

2018-01-01

Last updated by the study team

2015-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Patient scheduled to undergo abdominal surgery

You may not qualify if…

• Cannot consent or has no surrogate who can consent.
• Cognitive inability to follow directions to maintain abdominal device in place
• 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)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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