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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-26

Study Completion Date

2020-04-28

Brief Summary

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Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier NCT03689985) there were 2 participants.

This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ 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 smART™ 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, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).

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Detailed Description

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Conditions

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Aspiration Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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General

One arm study: smART Feeding Tube System.

Group Type EXPERIMENTAL

smART Feeding Tube System

Intervention Type DEVICE

Replacing generic feeding tube with smART Feeding Tube System.

Interventions

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smART Feeding Tube System

Replacing generic feeding tube with smART Feeding Tube System.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with anomalies or diseases of the esophagus and or stomach.
* Patients with known sensitivities or allergies to any of the feeding tube materials
* Inability to place patient in 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No