Optimizing the Previs Device for Prediction of Postoperative Ileus
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- STATUS
- Recruiting
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- days left to enroll
- 88
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- participants needed
- 225
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- sponsor
- Jennifer Hrabe
Summary
The research proposed in this study will develop a noninvasive prototype device that will capture intestinal sounds, process signals, and display predictive information in real-time at the point-of-care using algorithms already developed at this institution.
Description
Following major abdominal surgery, up to 30% of patients develop a poorly understood condition known as ileus. When ileus occurs, the bowels shut down and patients often develop abdominal dissension, nausea, vomiting, and even more serious complications. Because this condition does not develop until many days after surgery has been completed, clinicians do not know if they should begin allowing patients to eat or withhold nutrition until they show signs of bowel function such as passing gas or having bowel movements. Clinicians have different approaches but none are ideal: 1) feed all patients early and the ones that develop an ileus will have their diets reverse, suction tube placed in their stomach, and hopefully don't get develop more serious complications, or 2) don't feed patients until they pass gas or have a bowel movement, which delays nutrition and prolongs hospital stays for the 70% of patients who will not develop an ileus
Participants in this study will be asked to wear a 3-ounce device that adheres to the skin of the abdominal wall for 10 days. They will also be asked to answer questions each day of their hospital stay regarding how they have tolerated eating.
Details
| Condition | Ileus |
|---|---|
| Treatment | Entac Medical device application, Patient Daily Assessment, Patient Discharge Assessment |
| Clinical Study Identifier | NCT03505476 |
| Sponsor | Jennifer Hrabe |
| Last Modified on | 4 October 2022 |
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