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

Pancreatitis Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatitis

• NCT number: NCT02412826
• Study type: Observational
• Source: Cedars-Sinai Medical Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Completion date: April 2017