Optimizing the Previs Device for Prediction of Postoperative Ileus

J

Jennifer Hrabe

Status

Enrolling

Conditions

Ileus

Treatments

Other: Patient Daily Assessment
Other: Patient Discharge Assessment
Device: Entac Medical device application

Study type

Interventional

Funder types

Other

Identifiers

NCT03505476
201801808

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.

Age 18 to 100.

Exclusion criteria

Allergies to any of the device components. Inability to have prototype device applied to their abdominal wall due to a condition (ie:fistulas, stomas, drains, etc).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

225 participants in 1 patient group

Study Participants
Experimental group
Description:
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Treatment:
Other: Patient Discharge Assessment
Device: Entac Medical device application
Other: Patient Daily Assessment

Trial contacts and locations

1

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Central trial contact

Jessica Danielson; Debra OConnell Moore, MBA

Data sourced from clinicaltrials.gov

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