Optimizing the Previs Device for Prediction of Postoperative Ileus

Sponsor

Jennifer Hrabe (Other)

Overall Status

Recruiting

CT.gov ID

NCT03505476

Collaborator

(none)

225

Enrollment

Location

Arm

67.3

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ileus	Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All subjects consented and enrolled will receive the same intervention. There is no control group.All subjects consented and enrolled will receive the same intervention. There is no control group.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Optimizing the Previs Device for Prediction of Postoperative Ileus

Actual Study Start Date :

Apr 24, 2018

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Participants Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment	Device: Entac Medical device application Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first. Other: Patient Daily Assessment The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized. Other: Patient Discharge Assessment The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.

Arm

Intervention/Treatment

Experimental: Study Participants

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

Device: Entac Medical device application

Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first.

Other: Patient Daily Assessment

The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized.

Other: Patient Discharge Assessment

The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.

Outcome Measures

Primary Outcome Measures

Maximize the predictive value of the device for predicting postoperative GI impairment. [Each patient's data will be evaluated after 14 days. Each group of 10-30 patients' data will be analyzed. Final analysis will occur after 225 patients are enrolled.]
The signal processing algorithm will be modified iteratively to maximize the negative predictive value of the device while maintaining the highest PPV The sensitivity, specificity, positive predictive value, negative predictive value, AUC, and accuracy of the device for each 10-30 patients (dependent upon the incidence of GI impairment in each group) will be measured. The signal processing algorithm will be modified iteratively to maximize the negative predictive value of the device while maintaining the highest PPV possible. Our goal is for the AUC for the final algorithm to be greater than 0.8.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

Jennifer Hrabe

Investigators

Principal Investigator: Jennifer Hrabe, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Hrabe, Clinical Assistant Professor, University of Iowa

ClinicalTrials.gov Identifier:

NCT03505476

Other Study ID Numbers:

201801808

First Posted:

Apr 23, 2018

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Jennifer Hrabe, Clinical Assistant Professor, University of Iowa

Additional relevant MeSH terms:

Ileus

Study Results

No Results Posted as of Jul 14, 2022