Recruiting

Observational Study

Sponsor:

VA Greater Los Angeles Healthcare System

Code:

NCT02065583

Conditions

Post Operative Ileus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Post Operative Ileus

Study ID

NCT02065583

Start date

Dec, 2013

Status verified date

Dec, 2015

Completion date

Jan, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

GI abdominal surgery patients

Patients recovering from gastrointestinal abdominal surgery.

Primary outcome measure

  • Count of motility events per minute. [ Time Frame: 1 minute ]

Central Contacts and Locations

Central contacts

Jennifer Talley, MSPH

310-423-0508Jennifer.Soares@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Brennan MR Spiegel, MD, MSHS

310-423-6467brennan.spiegel@cshs.org

More Information

Sponsor

VA Greater Los Angeles Healthcare System

Last update posted

Dec 11, 2015

Last verified

Dec, 2015

Keywords

  • Ileus
  • Equipment and Supplies
  • Technology
  • Acoustics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Greater Los Angeles Healthcare System on 2015-12-11.