Optimizing the Previs Device for Prediction of Postoperative Ileus

Not Applicable

Completed

Conditions: Ileus

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

Registration Number: NCT03505476

Lead Sponsor: Jennifer Hrabe

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 203

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Participants	Patient Discharge Assessment	Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Study Participants	Entac Medical device application	Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Study Participants	Patient Daily Assessment	Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment

Primary Outcome Measures

Name	Time	Method
Device Sensitivity for Predicting Ileus.	Each patient's device's data was assessed at day 15.	Calculate the sensitivity of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with ileus that the device did not predict (true positive + false negative).
Device Specificity for Predicting Ileus	Each patient's device's data was assessed at day 15.	Calculate the specificity of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicting no ileus and device incorrectly predicting ileus (true negative plus false positive).
Device Positive Predictive Value for Predicting Ileus	Each patient's device's data was assessed at day 15.	Calculate the positive predictive value of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with device incorrectly predicting ileus (true positive plus false positive).
Device Negative Predictive Value for Predicting Ileus	Each patient's device's data was assessed at day 15.	Calculate the negative predictive value of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicted no ileus and with ileus the device did not predict (true negative plus false negative).