Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedStudy Start
First participant enrolled
January 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2022
CompletedResults Posted
Study results publicly available
May 29, 2025
CompletedMay 29, 2025
May 1, 2025
2.2 years
September 19, 2019
October 30, 2023
May 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Device Safety According to Occurrence or Absence of Related AE Adverse Event or SAE Serious Adverse Events
2 days-14 days
Decrease in Intensive Critical Unit Length of Stay
from admission to discharge from ICU ('ICU length of stay')
Reduction of Number of Patients With VAE (Ventilation Associated Events)
2 days-14 days
Decrease in ICU Ventilation Days
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
2 days-14 days
- +2 more secondary outcomes
Study Arms (2)
Interventional Device - Treated
EXPERIMENTALSubjects connected to the investigational device smART+
Control Group
NO INTERVENTIONtreated according to local Standard of Care.
Interventions
Utilizing the smART+ System to provide feeding optimization to the patient
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ART Medical Ltd.lead
Study Sites (1)
Beilinson Hospital
Petah Tikva, Isreal, 4941492, Israel
Related Publications (1)
Kagan I, Hellerman-Itzhaki M, Bendavid I, Statlender L, Fishman G, Wischmeyer PE, de Waele E, Singer P. Controlled enteral nutrition in critical care patients - A randomized clinical trial of a novel management system. Clin Nutr. 2023 Sep;42(9):1602-1609. doi: 10.1016/j.clnu.2023.06.018. Epub 2023 Jul 7.
PMID: 37480797DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was designed to detect an effect size of 0.45 for 100 patients per group (200 total enrollment) using a two- group test with a 0.05 two-sided significance level. A single interim analysis was planned after 100 patients. The trial was stopped after the interim analysis of the available data of the 100 enrolled patients, as sufficient data was collected.
Results Point of Contact
- Title
- Mrs. Shirly Steinlauf
- Organization
- ART MEDICAL
Study Officials
- PRINCIPAL INVESTIGATOR
Ilya Kagan, MD
Beilinson Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2019
First Posted
September 23, 2019
Study Start
January 12, 2020
Primary Completion
March 10, 2022
Study Completion
November 7, 2022
Last Updated
May 29, 2025
Results First Posted
May 29, 2025
Record last verified: 2025-05