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

NCT02677909 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-08-21

No results posted yet for this study

Summary

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.

Conditions

  • Critical Illness

Interventions

DEVICE

AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Will place device on admission to SICU. Measure bowel sounds and await bowel function

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-01-31
Completion
2021-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02677909 on ClinicalTrials.gov