PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later. The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
The PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. Under normal conditions, transformations of the data are visualized on the display. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants.
Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando
Orlando, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGSpectrum Health Blodgett Hospital
Grand Rapids, Michigan, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGThe University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGThe Cleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGOregon Health and Science University
Portland, Oregon, United States
RECRUITINGPerformance of the PrevisEA device
The performance (accuracy) of the device in predicting development of GII will be assessed through evaluation of the primary outcome measures of sensitivity and specificity for the device.
Time frame: 1-14 days
Positive predictive value (PPV)
Measures will be analyzed by using available data only
Time frame: 1-14 days
Negative predictive value (NPV)
Measures will be analyzed by using available data only
Time frame: 1-14 days
Overall percent agreement (OPA)
Measures will be analyzed by using available data only
Time frame: 1-14 days
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