Clinical Trial: Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings

Brief Summary: This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smARTrack™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrack™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smARTrack™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.

Detailed Summary:
Sponsor: ART Healthcare ltd.

Current Primary Outcome:

  • System accurately guides correct initial placement [ Time Frame: 24-72 hours ]
    The system is able to accurately guide the user to ensure correct initial placement (verified by X-ray)
  • System accurately detects tube movement/displacement during ongoing use [ Time Frame: 24-72 hours ]
    The system is able to detect tube movement/displacement during ongoing use (verified by markings on the tube)
  • System automatically stops feeding when displacement is detected [ Time Frame: 24-72 hours ]
    The system automatically stops feeding when tube displacement is detected
  • System is able to detect overfeeding [ Time Frame: 24-72 hours ]
    The system is able to detect overfeeding
  • Occurrence of device related Adverse Events (Safety) [ Time Frame: 24-72 hours ]
    Occurrence of device related adverse events


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: ART Healthcare ltd.

Dates:
Date Received: February 9, 2016
Date Started: April 2016
Date Completion:
Last Updated: July 13, 2016
Last Verified: July 2016