Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study

Nutrition Monitoring and Feeding Optimization With the smART+ System

The smART+ is a comprehensive modular patient care system intended for ICU patients.

The main purpose of the study is the optimization of the delivery of nutrition.

The use of the smART+ Feeding tube includes a feature of facilitating correct tube placement and alerting when the tube is displaced during ongoing use. The system will automatically stop feeding if displacement is detected. If a massive reflux episode is detected by the system, a balloon located on the tube will automatically inflate and automatic GRV feature will open to prevent gastric content from regurgitating to the esophagus.

In addition to tube placement, the system allows to obtain REE (Resting Energy Expenditure) measurements and calculates the optimized nutritional values required by the patient. Furthermore, the system optimizes feeding by compensating for any lost feeding time or discarded nutritional content that was discarded via the GRV (Gastric Residual Volume).

Study participants will be randomly assigned to a study group:

Group A- ICU patients receiving the investigational device ("Treated"). Group B- Control group.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Aspiration Pneumonia
• Intervention / Treatment: Device: smART+ System

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Isreal
    • Petah Tikva, Isreal, Israel, 4941492
      • Beilinson Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females 18 years or older
• Patient that have already been admitted to the ICU (no more than 48 hours before enrollment)
• Expected to be ventilated at least 48 hours after enrollments.
• Patient requires enteral feeding (by naso/oro-gastric feeding tube)

Exclusion Criteria:

• Pregnant women
• Known anatomical anomalies of the nose, oral cavity esophagus or the stomach that may prevent/hinder the ability to insert the feeding tube

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Device - Treated; Subjects connected to the investigational device smART+	Device: smART+ System; Utilizing the smART+ System to provide feeding optimization to the patient
No Intervention: Control Group; treated according to local Standard of Care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition optimization	Optimization of the delivery of nutrition by the smART+ System as compared to standard of care, by automatically calculating and administering enteral feeding better than standard of care (REE or Calorimeter).	2 days-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Safety according to occurrence or absence of related AE or SAE	Safe use of the entire system will be assessed based on the occurrence of device-related AE or SAE.	2 days-14 days
Decrease in ICU length of stay	Measured from admission to ICU until the decision to discharge is ordered.	2 days-14 days
Reduction of VAE (Ventilation Associated Events)	According to the definition from the latest CDC	2 days-14 days
Decrease in ventilation days	Evaluated by the number of hours of etCO2 from the hospital electronic records	2 days-14 days
Decrease in workload related to nurse GRV time	the change in workload could be estimated by using the estimated nursing time that was expended for GRV activities, and the amounts of GRV removed from the patient obtained through the hospital's electronic records and also the usability questionnaires	2 days-14 days
Assessment of urine flow monitoring related to patient condition	Patient lab results obtained through the hospital's electronic records will be analyzed against smART+ system urine alerts to determine if the alerts will be useful in the diagnosis	2 days-14 days
Convenience of use of the system and the user interface (by subjective staff questionnaire)	Evaluated via questionnaires filled by physician users and nurse users participating in the study	Through study completion in each site, an average of 1 year

Collaborators and Investigators

• Sponsor: ART Medical Ltd.
• Investigators: Principal Investigator: Ilya Kagan, MD, Beilinson Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2020
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): February 24, 2022

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Nutrition Disorders; Malnutrition; Pneumonia, Aspiration
• Other Study ID Numbers: CRO-C-2822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No