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

Primary Purpose

Aspiration Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
smARTrack Feeding Tube System
Sponsored by
ART Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aspiration Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

General

Arm Description

One arm study: smARTrack Feeding Tube System.

Outcomes

Primary Outcome Measures

System accurately guides correct initial placement
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
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
The system automatically stops feeding when tube displacement is detected
System is able to detect overfeeding
The system is able to detect overfeeding
Occurrence of device related Adverse Events (Safety)
Occurrence of device related adverse events

Secondary Outcome Measures

The system user interface is easy for use
Ease of use of the system and the user interface by subjective questionnaire of staff
Correlation of impedance detected to patient positioning
Recording of impedance detected by the system and correlation to patient positioning
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
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).
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.

Full Information

First Posted
February 9, 2016
Last Updated
September 21, 2020
Sponsor
ART Medical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02705781
Brief Title
Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings
Official Title
Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 23, 2016 (Actual)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ART Medical Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General
Arm Type
Experimental
Arm Description
One arm study: smARTrack Feeding Tube System.
Intervention Type
Device
Intervention Name(s)
smARTrack Feeding Tube System
Primary Outcome Measure Information:
Title
System accurately guides correct initial placement
Description
The system is able to accurately guide the user to ensure correct initial placement (verified by X-ray)
Time Frame
24-72 hours
Title
System accurately detects tube movement/displacement during ongoing use
Description
The system is able to detect tube movement/displacement during ongoing use (verified by markings on the tube)
Time Frame
24-72 hours
Title
System automatically stops feeding when displacement is detected
Description
The system automatically stops feeding when tube displacement is detected
Time Frame
24-72 hours
Title
System is able to detect overfeeding
Description
The system is able to detect overfeeding
Time Frame
24-72 hours
Title
Occurrence of device related Adverse Events (Safety)
Description
Occurrence of device related adverse events
Time Frame
24-72 hours
Secondary Outcome Measure Information:
Title
The system user interface is easy for use
Description
Ease of use of the system and the user interface by subjective questionnaire of staff
Time Frame
24-72 hours
Title
Correlation of impedance detected to patient positioning
Description
Recording of impedance detected by the system and correlation to patient positioning
Time Frame
24-72 hours
Title
Quantification of the amount of discarded nutritional supplement by implementing GRV test
Description
Quantification of the amount of discarded nutritional supplement by implementing GRV test as needed and according to hospital procedures
Time Frame
24-72 hours
Title
Aspiration of gastric contents percentage compared to standard feeding (as reported in literature)
Description
Reduction of aspiration of gastric contents percentage compared to standard feeding (as reported in literature).
Time Frame
24-72 hours
Title
Correlation between patient clinical information and the occurrence of reflux and sensors data
Description
Correlation between patient clinical information and the occurrence of reflux and sensors data.
Time Frame
24-72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

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

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