Abstats: Computer-aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Acute Pancreatitis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | April 2017 |
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.
patients with acute pancreatitis to determine the correlation of acoustic signals with
symptoms reported by the patient.
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.
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.
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
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