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

Aspiration Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705781
• Other study ID #: EXC_SYT_P001
• Status: Completed
• Phase: N/A
• Start date: March 23, 2016
• Est. completion date: August 14, 2018

Study information

• Verified date: September 2020
• Source: ART Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 14, 2018
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration

Intervention

Device:
• smARTrack Feeding Tube System

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
ART Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	System automatically stops feeding when displacement is detected	The system automatically stops feeding when tube displacement is detected	24-72 hours
Primary	System is able to detect overfeeding	The system is able to detect overfeeding	24-72 hours
Primary	Occurrence of device related Adverse Events (Safety)	Occurrence of device related adverse events	24-72 hours
Secondary	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
Secondary	Correlation of impedance detected to patient positioning	Recording of impedance detected by the system and correlation to patient positioning	24-72 hours
Secondary	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
Secondary	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
Secondary	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