Computer-Aided, Non-Invasive, Acoustic Gastrointestinal Surveillance (AGIS) in ICU Patients



Status:Active, not recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:7/20/2018
Start Date:January 1, 2018
End Date:July 2021

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In this study, the investigators aim to conduct a pilot test of the AbStats device. The v2.0
prototype is a low-profile set of sensors that fits externally around the abdomen and is
embedded with specialized wireless sensors. The device continuously, safely, and comfortably
monitors intraabdominal acoustic signals, and stores the data in a HIPAA compliant software
system.

The investigators will focus this trial on a high-impact inpatient population: ileus in the
surgical critical care unit. The investigators will compare the device's signal profiles in
patients with ileus vs those who tolerate feeding without high gastric feed residual. Our
study will have the following specific aims:

Specific Aim #1: To measure the sensitivity, specificity, positive predictive value (PPV),
and negative predictive value (NPV) of initiation day ("PID 0") AGIS signals in predicting
PID #1 feeding failure. Specific Aim #2: Among patients tolerating feeds on PID #1, to
measure the sensitivity, specificity, PPV, and NPV of AGIS in predicting feeding failure on
subsequent icu days.

The AGIS device consists of two acoustic sensors placed on the abdomen to "hear" all segments
of the abdominal cavity. Other sensor configurations are possible as needed. Initial testing
of this device was conducted at UCLA and VA-Wadsworth under separate IRB approval; however,
at this time, all remaining human subjects will be enrolled at CSMC only. We will collect
AGIS data in patients undergoing GI abdominal surgery on the day of surgery and throughout
their inpatient hospital course.

We will recruit patients who are already scheduled to undergo GI abdominal surgery. The
AbStats/AGIS system will be utilized to measure and analyze bowel sounds and correlate with
clinical findings. We will exclude subjects who cannot consent, have cognitive inability to
follow directions, or have any abdominal wall condition that disallows topical coverage as
deemed by the treating physician (e.g. abdominal wound, advanced cellulitis, etc.). We will
obtain consent from the patient for incorporating the AGIS device during the inpatient stay.
The technical staff will be oriented to the device. However, a physician member of our staff
will be available at all times to help position the device if needed. A research coordinator
will collect clinical data and enter the data into a secure spreadsheet. Study team members
willcollect the following data from patient medical records once patients have consented for
the study: Age, Sex, Race/Ethnicity, Body Mass Index (BMI), Abdominal symptoms per chart
review, abdominal examination findings per chart review, days in the ICU, days in step down
monitoring unit, days in ward, daily vital signs in proximity to the time device is worn,
including temperature recordings, respiratory rate recordings, heart rate recordings, blood
pressure recordings, and medication usage. Patient data pertaining to their return to bowel
function will be abstracted, including: date/time bowel sounds first recorded in chart,
date/time first flatus recorded in chart, date/time first bowel movement recorded in chart,
date/time of any vomiting episodes, date/time oral diet initiated, amount of diet tolerating,
need for placement of nasogastric decompression tubes. Patients will be asked to fill out
diaries of their symptoms when possible.

Inclusion Criteria:

- 18 years or older

- Admission to the SICU

Exclusion Criteria:

- Unable to place sensors on patients
We found this trial at
1
site
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
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