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Completed

NCT Number: NCT02705781

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.

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Key information

Conditions

Aspiration Pneumonia Infections Lung Diseases Pneumonia Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus

Haifa, 31096, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

smARTrack Feeding Tube System

Device

Primary outcomes

  1. 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)

  2. 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)

  3. System automatically stops feeding when displacement is detected

    Time frame: 24-72 hours

    The system automatically stops feeding when tube displacement is detected

  4. System is able to detect overfeeding

    Time frame: 24-72 hours

    The system is able to detect overfeeding

  5. Occurrence of device related Adverse Events (Safety)

    Time frame: 24-72 hours

    Occurrence of device related adverse events

Secondary outcomes

  1. The system user interface is easy for use

    Time frame: 24-72 hours

    Ease of use of the system and the user interface by subjective questionnaire of staff

  2. Correlation of impedance detected to patient positioning

    Time frame: 24-72 hours

    Recording of impedance detected by the system and correlation to patient positioning

  3. Quantification of the amount of discarded nutritional supplement by implementing GRV test

    Time frame: 24-72 hours

    Quantification of the amount of discarded nutritional supplement by implementing GRV test as needed and according to hospital procedures

  4. Aspiration of gastric contents percentage compared to standard feeding (as reported in literature)

    Time frame: 24-72 hours

    Reduction of aspiration of gastric contents percentage compared to standard feeding (as reported in literature).

  5. Correlation between patient clinical information and the occurrence of reflux and sensors data

    Time frame: 24-72 hours

    Correlation between patient clinical information and the occurrence of reflux and sensors data.

Sponsors and collaborators

Lead sponsor

ART Medical Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 11, 2016
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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