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Critical IllnessNCT02677909

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

An observational study of Critical Illness, run by Cedars-Sinai Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness
What is being tested?
AEGIS (Automated Evaluation of Gastrointestinal Symptoms)
Type of treatment
Medical device
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2018to Jul 2021
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Surgical intensive care patients

Who may be able to join

  • 18 years or older
  • Admission to the SICU

Who cannot join

  • Unable to place sensors on patients

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cedars-Sinai Medical Center

    Beverly Hills, California, 90048

Other trials in United States

About this study

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.

Read the 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.

Being tested
AEGIS (Automated Evaluation of Gastrointestinal Symptoms)
Keywords
Parenteral Nutrition, Critical Care
Medical subject headings
Critical Illness, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AEGIS (Automated Evaluation of Gastrointestinal Symptoms)Device

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Count of motility events per minute

    Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2016 (estimated)
  2. Study start1 Jan 2018 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionJul 2021 (estimated)

Why it stopped: Did not receive sensors from device company and did not initiate enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT02677909
Sponsor's protocol ID
01-2016
Status last verified
Aug 2019
First submitted
5 Feb 2016
Last updated
21 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count of motility events per minute (time frame: 1 minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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