N/A
N=100
Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
Aspiration Pneumonia · Malnutrition
Bottom Line
View on ClinicalTrials.gov: NCT04098224 ↗Enrolled (actual)
100
Serious AEs
6.0%
Results posted
May 2025
Primary outcome: Primary: Nutrition Optimization — 89.5; 65 percentage of feeding efficiency
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- smART+ System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ART Medical Ltd.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nutrition Optimization |
89.5; 65 | — |
| SECONDARY Device Safety According to Occurrence or Absence of Related AE Adverse Event or SAE Serious Adverse Events |
0; 0; 3; 3 | — |
| SECONDARY Decrease in Intensive Critical Unit Length of Stay |
10.37; 13.65 | — |
| SECONDARY Reduction of Number of Patients With VAE (Ventilation Associated Events) |
1; 5 | — |
| SECONDARY Decrease in ICU Ventilation Days |
9.52; 12.78 | — |
| SECONDARY Decrease in Workload Related to Nurse Gastric Residual Volume (GRV) Time |
124.25; 166.10; 33.3941; 114.95 | — |
| SECONDARY Assessment of Urine Flow Monitoring Related to Patient Condition |
— | — |
| SECONDARY Convenience of Use of the System and the User Interface (by Subjective Staff Questionnaire) |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04098224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.