Clinical trial NCT02412826: Abstats: Computer-aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Acute Pancreatitis
Official title: Abstats: Computer-aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatitis
Keywords: pancreatitis
acoustic
sensor
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Re-hospitalization for acute pancreatitis
timeFrame: 30 days
measure: Ability to PO after discharge
timeFrame: 30 days
measure: Symptoms
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Elham Afghani, MD
role: PRINCIPAL_INVESTIGATOR
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