Optimizing the Previs Device for Prediction of Postoperative Ileus

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.

Study Overview

• Status: Recruiting
• Conditions: Ileus
• Intervention / Treatment: Device: Entac Medical device application; Other: Patient Daily Assessment; Other: Patient Discharge Assessment

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 Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Danielson; Phone Number: 319-356-1722; Email: jessica-danielson@uiowa.edu
• Study Contact Backup: Name: Debra OConnell Moore, MBA; Phone Number: 319-356-1693; Email: debra-oconnell-moore@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Kimberly Sprenger; Phone Number: 319-353-8862; Email: kimberly-sprenger@uiowa.edu
      • Contact: Jessica Danielson; Phone Number: 319-356-1722; Email: jessica-danielson@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximize the predictive value of the device for predicting postoperative GI impairment.	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.	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.

Collaborators and Investigators

• Sponsor: Jennifer Hrabe
• Investigators: Principal Investigator: Jennifer Hrabe, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Ileus; Abdominal surgery; Bowel obstruction; Ileus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: 201801808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes