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

NCT02677909 | Withdrawn

• 1 other identifier: 01-2016
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Parenteral Nutrition; Critical Care

Outcome Measures

Primary Outcomes (1)

• Count of motility events per minute

  1 minute

Interventions

AEGIS (Automated Evaluation of Gastrointestinal Symptoms) DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical intensive care patients

You may qualify if:

• years or older
• Admission to the SICU

You may not qualify if:

• Unable to place sensors on patients

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Beverly Hills, California, 90048, United States

Location

MeSH Terms

Conditions

Critical Illness; Hyperphagia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: January 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)