Abstats: Computer-aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Acute Pancreatitis

March 1, 2016 updated by: Elham Afghani, Cedars-Sinai Medical Center
The purpose of this study is to conduct a pilot test of an abdominal acoustic sensor on patients with acute pancreatitis to determine the correlation of acoustic signals with symptoms reported by the patient.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will use the AbStats device, that measure IAAS (intraabdominal acoustic signals) and intestinal rate and will correlate this data with symptoms reported by patients hospitalized for acute pancreatitis.

The AbStats multi-sensor wireless abdominal monitoring system includes low profile acoustic sensors that are applied to the anterior abdominal wall with Tegaderm and monitors sounds emanating from the GI tract. The acoustic sensors continuously and non-invasively monitor and capture audio signals representing GI and abdominal wall function. The captured data is recorded in a synchronized manner from all sensors.

We will place the AbStats sensor on all patients immediately after admission to the hospital. Only study staff trained on the AbStats system will apply the sensors, which fit externally around the abdomen. A physician member of our study staff will be available at all times to help position the device if needed. We will continuously record AbStats acoustic signals for the duration of the hospitalization, with the option to discontinue as clinically required or requested by the provider or patient. A research coordinator will collect clinical data from medical records and enter the data into a secure spreadsheet on CSMC servers. Patients will be asked to keep a daily diary of symptoms. In this diary, the patients will be asked to record information about their food consumption (if any), bowel movements (if any and if associated with contrast from CT imaging or with the use of suppositories/ laxative), specific symptoms, and whether the sensor was removed for any period of time during the day. This will allow us to compare the data collected by the AbStats sensor with self-reported symptoms noted by patients. Physicians and nurses will not be made aware of the AbStats readings so as to eliminate the Hawthorne effect. Patients will be managed according to standard-of-care practice and the data collected by the AbStats device will not be incorporated into clinical care.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be patients who present to Cedars-Sinai Medical Center with the diagnosis of acute pancreatitis.

Description

Inclusion Criteria:

  • 18 years of age and older

  • diagnosis of acute pancreatitis; must meet at least 2 out of the 3 following critiera:

    1. abdominal pain consistent with acute pancreatitis
    2. serum amylase/lipase >3 times upper limit of normal
    3. characteristic findings from abdominal imaging
  • able to provide informed consent

Exclusion Criteria:

  • unable to provide consent
  • transfer patients
  • cognitive inability to follow directions to maintain sensors in place
  • unable to place abdominal sensors on patients
  • abdominal cellulitis
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute pancreatitis
Patients presenting to the hospital with acute pancreatitis that will receive AbStats sensor
Device: Abstats sensor
The AbStats abdominal biosensor will be applied to the abdomen of patients who are admitted with acute pancreatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-hospitalization for acute pancreatitis
Time Frame: 30 days
Patients who are re-admitted to the hospital for acute pancreatitis
30 days
Ability to PO after discharge
Time Frame: 30 days
Patients who are able to tolerate oral itnake after discharge
30 days
Symptoms
Time Frame: 30 days
GI symptoms after discharge
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Elham Afghani, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00038455

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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