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

ART Medical

Status: Completed

Conditions: Aspiration Pneumonia

Treatments: Device: smARTrack Feeding Tube System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02705781

EXC_SYT_P001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

General

Experimental group

Description:

One arm study: smARTrack Feeding Tube System.

Treatment:

Device: smARTrack Feeding Tube System