Computer-Aided, Non-Invasive, Acoustic Gastrointestinal Surveillance (AGIS) in ICU Patients
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
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.
Study Type
Study Type
Contacts and Locations
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years or older
- Admission to the SICU
Exclusion Criteria:
- Unable to place sensors on patients
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Count of motility events per minute
Time Frame: 1 minute
|
1 minute
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 01-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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