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

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.

Study Overview

• Status: Completed
• Conditions: Aspiration Pneumonia
• Intervention / Treatment: Device: smARTrack Feeding Tube System

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females 18 years or older
• Patient has already been admitted to ICU
• Patient requires enteral feeding
• Patients receiving PPI therapy
• Informed consent by independent physician and next of kin
• ICU ventilated patients

Exclusion Criteria:

• Patients with anomalies or diseases of the nose, throat, or esophagus and or stomach.
• Patients with known sensitivities or allergies to any of the feeding tube materials
• Inability to place patient is semi-Fowler's position.
• Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder)
• Pregnancy
• Recent abdominal surgery (less than 30 days)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• 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: General; One arm study: smARTrack Feeding Tube System.	Device: smARTrack Feeding Tube System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The system user interface is easy for use	Ease of use of the system and the user interface by subjective questionnaire of staff	24-72 hours
Correlation of impedance detected to patient positioning	Recording of impedance detected by the system and correlation to patient positioning	24-72 hours
Quantification of the amount of discarded nutritional supplement by implementing GRV test	Quantification of the amount of discarded nutritional supplement by implementing GRV test as needed and according to hospital procedures	24-72 hours
Aspiration of gastric contents percentage compared to standard feeding (as reported in literature)	Reduction of aspiration of gastric contents percentage compared to standard feeding (as reported in literature).	24-72 hours
Correlation between patient clinical information and the occurrence of reflux and sensors data	Correlation between patient clinical information and the occurrence of reflux and sensors data.	24-72 hours

Collaborators and Investigators

• Sponsor: ART Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2016
• Primary Completion (Actual): November 8, 2017
• Study Completion (Actual): August 14, 2018

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Pneumonia, Aspiration
• Other Study ID Numbers: EXC_SYT_P001