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.
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
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.
- Conditions
- Critical Illness
- 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.
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.
- First posted9 Feb 2016 (estimated)
- Study start1 Jan 2018 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: Did not receive sensors from device company and did not initiate enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Matthew Bloom, Cedars-Sinai Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Aided, Non-Invasive, Acoustic Gastrointestinal Surveillance (AGIS) in ICU Patients
- ClinicalTrials.gov ID
- NCT02677909
- Acronym / sponsor ID
- 01-2016
- Conditions
- Critical Illness
- Keywords
- Parenteral Nutrition, Critical Care
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Did not receive sensors from device company and did not initiate enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical intensive care patients
Key inclusion criteria (2 listed)
- 18 years or older
- Admission to the SICU
Key exclusion criteria (1 listed)
- Unable to place sensors on patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AEGIS (Automated Evaluation of Gastrointestinal Symptoms)Will place device on admission to SICU. Measure bowel sounds and await bowel function | Device | – |
Primary outcome
Count of motility events per minute
Time frame: 1 minute
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.