This feasibility study is for the purpose of determining if the G-Tech Device can differentiate between normal return of GI activity post-operatively and the myoelectric activity in patients who develop a POI.
While preventing the development of a POI is most important, POIs still occur; therefore, it is important to definitively diagnose a POI as early as possible during the post-operative course for treatment to prevent patient discomfort, complications, and extended hospital stay. The purpose of the G-Tech study is to determine if the G-Tech Device can detect a difference in the myoelectric signals from patients who develop a POI compared to those patients who do not develop a POI. It is anticipated that up to 20% of patients enrolled in this study and consented preoperatively, excluding screen failures, will show evidence of a post-operative ileus as detected by the G-Tech GutCheck Device and differentiate the myoelectric signals from the patients who do not develop a POI. Patients who are known to have developed a POI may also be selected for the study.
Study Type
OBSERVATIONAL
Enrollment
150
A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.
El Camino Hospital
Mountain View, California, United States
RECRUITINGMyoelectric activity pattern in POI patients versus non-POI patients
The resumption of motor activity in the stomach, small intestine, and colon post-operatively. The measurement is myoelectric signals measured at the skin surface similar to ECG recordings for the heart
Time frame: Up to 6 Days
Anticipated Adverse Events
Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.
Time frame: Up to 6 days
UADEs
Unanticipated adverse device effects
Time frame: Up to 6 Days
Device Success
Device success defined as the ability to record GI myoelectric activity following GI surgery.
Time frame: Up to 6 Days
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