Predictive Validity of Acoustic Gastrointestinal Surveillance (AGIS) in Post-Operative Feeding
AGIS
Predictive Validity of a Computer-Aided, Non-Invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Post-Operative Feeding
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 20, 2013
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedDecember 11, 2015
December 1, 2015
4.1 years
December 20, 2013
December 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Count of motility events per minute.
The primary unit of analysis will be the number of motility events registered by the AGIS sensor per minute.
1 minute
Study Arms (1)
GI abdominal surgery patients
Patients recovering from gastrointestinal abdominal surgery.
Eligibility Criteria
The investigators will recruit patients who are scheduled for GI abdominal surgery at Cedars-Sinai Medical Center
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Related Publications (1)
Kaneshiro M, Kaiser W, Pourmorady J, Fleshner P, Russell M, Zaghiyan K, Lin A, Martinez B, Patel A, Nguyen A, Singh D, Zegarski V, Reid M, Dailey F, Xu J, Robbins K, Spiegel B. Postoperative Gastrointestinal Telemetry with an Acoustic Biosensor Predicts Ileus vs. Uneventful GI Recovery. J Gastrointest Surg. 2016 Jan;20(1):132-9; discussion 139. doi: 10.1007/s11605-015-2956-3. Epub 2015 Sep 25.
PMID: 26408329DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brennan Spiegel, MD, MSHS
Cedars-Sinai Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Health Services Research
Study Record Dates
First Submitted
December 20, 2013
First Posted
February 19, 2014
Study Start
December 1, 2013
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
December 11, 2015
Record last verified: 2015-12