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Optimizing the Previs Device for Prediction of Postoperative Ileus

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ClinicalTrials.gov Identifier: NCT03505476
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Hrabe, University of Iowa

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
Maximize the predictive value of the device for predicting postoperative GI impairment. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03505476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing the Previs Device for Prediction of Postoperative Ileus
Official Title  ICMJE Optimizing the Previs Device for Prediction of Postoperative Ileus
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
All subjects consented and enrolled will receive the same intervention. There is no control group.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Ileus
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Study Participants
Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment
Interventions:
  • Device: Entac Medical device application
  • Other: Patient Daily Assessment
  • Other: Patient Discharge Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Debra OConnell Moore, MBA 319-356-1693 debra-oconnell-moore@uiowa.edu
Contact: Jessica Danielson 319-356-1722 jessica-danielson@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03505476
Other Study ID Numbers  ICMJE 201801808
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer Hrabe, University of Iowa
Study Sponsor  ICMJE Jennifer Hrabe
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Hrabe University of Iowa
PRS Account University of Iowa
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP