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 (Gastric Residual Volume) 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

Detailed Description

Mechanically ventilated patients are unable to take food orally and therefore are dependent on enteral nutrition for provision of both energy and protein requirements. The conditions of ICU patients dramatically change throughout their ICU stay; "diseases, like particularly sepsis, trauma and burns, cause clinically relevant increase in resting energy expenditure (REE) of between 40% - 80%," and most patients do not reach their required protein and caloric targets. The American association for Parenteral and Enteral Nutrition (ASPEN) recommends that for patients who are at high risk for malnutrition, efforts should be made to provide >80% of the estimated or calculated energy and protein goal within 48-72 hours, starting with half the patient's calorie goal with the rate slowly increasing over time, in order to achieve the clinical benefit of enteral nutrition over the first week of hospitalization. However, studies have shown that more than 74% of ICU patients failed to receive at least 80% of their prescribed nutrition.

Predictive equations (such as Harris-Benedict equation) or a simple weight-based formula (48.1% and 48.7% respectively) have therefore been the most practiced methods of determining energy needs; however, the literature clearly indicates that each equation has a large potential for error. This makes it difficult to accurately predict an individual patient's energy requirements during critical illness. In general, predictive equations estimate accurately only 50% of the time in ICU patients, leading to over or under evaluation of the nutritional needs and inducing over or underfeeding. Numerous meta-analyses have demonstrated the poor value of predictive equations variability that is increased because body weight remains a value difficult to accurately assess.

To overcome the inaccuracy in determining the patient's energy consumption and the accompanying problems, the European Society for Parenteral and Enteral Nutrition (ESPEN) guidelines recommend to determine patients' REE based on indirect calorimetry or VCO2-based equation (VCO2 x 8.19). Unfortunately, this is not performed continuously during the course of enteral feeding to assess the ever-changing nutritional needs of the patient. Estimations showed that only 2% of ICUs were regularly using REE / indirect calorimetry,11 and therefore they must resort to performing a one-time calculation of the patient's energy consumption to manually calculate the caloric intake, food type and feeding rate.

This study aims to assess the accuracy of the smART+ System's REE module, compared to (1) the FDA-cleared COSMED device, and (2) nutritional calculations conducted with predictive equations regularly used by the clinical staff at the site.

• 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

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). The primary endpoint was the average feeding deviation between Days 2-14. Feeding deviation percentage was defined as the percentage of deviation from the nutrition target, calculated as the absolute value of 100 X (volume of nutrition delivered (mL) / the volume intended to be delivered (VTBD; mL))	2 days-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Safety According to Occurrence or Absence of Related AE Adverse Event or SAE Serious Adverse Events	Safe use of the entire system will be assessed based on the occurrence of device-related AE adverse event or SAE Serious Adverse Events.	2 days-14 days
Decrease in Intensive Critical Unit Length of Stay	Measured from admission to Intensive Critical Unit until the decision to discharge is ordered.	from admission to discharge from ICU ('ICU length of stay')
Reduction of Number of Patients With VAE (Ventilation Associated Events)	Ventilated associated events (VAE) was evaluated by modifications of FIO2 fraction of inspired oxygen (above .2) or PEEP Positive end-expiratory pressure (above 3 cm H20) requirements that were longer than 48 hours [per the CDC Centers for Disease Control and Prevention definition and clinical judgment of the interpreting physician]	2 days-14 days
Decrease in ICU Ventilation Days	Evaluated by the number of hours of End-tidal CO2 from the hospital electronic records	from admission to discharge from ICU ('ICU length of stay') up to 14 days.
Decrease in Workload Related to Nurse Gastric Residual Volume (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.	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)	Subjective staff questionnaire to be completed by all personnel involved in the study, to assess usability. In order to assess this endpoint a larger sample size is required. This secondary endpoint was omitted from the study because the study enrollment was stopped after the primary endpoint of feeding efficוency was achieved (100 patients enrolled).	Throughout the study

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): March 10, 2022
• Study Completion (Actual): November 7, 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): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; 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