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Controlled enteral nutrition in critical care patients –
A randomized clinical trial of a novel management system

Comparative, prospective,
stratified randomized study

Dr. Ilya Kagan, Dr. Moran Hellerman-Itzhaki, Dr. Itai Bendavid, Dr. Liran Statlender, Dr. Guy Fishman, Prof. Paul E Wischmeyer, Prof. Elisabeth de Waele, Prof. Pierre Singer

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smART+™ Platform

A holistic solution, designed to reduce the risk of ICU-acquired complications such as malnutrition, ventilator-associated events and AKI.

About the study

The study examined the smART+ Platform’s potential to deliver targeted nutrition and improve ICU outcomes.

The patients were randomized into two groups: a control group (N = 50) that received nutrition using standard (manual) practices, and a treatment group (N = 50) that utilized the smART+ Platform. Both groups received nutrition according to ESPEN guidelines.

The study was stopped due to success in a planned interim analysis of the first 100 patients.

Safety

No treatment-related adverse events occurred in either group.

Key Inclusion Criteria

  • ≥18 years old
  • No GI anatomical variation
  • Mechanical ventilation planned for ≥48h
  • Planned enteral feeding for 2-14 days

KEY EXCLUSION CRITERIA

  • Imminent death
  • Abnormalities of the feeding canal from nose/ mouth to stomach that could have hindered placement of the NGT
  • Pregnancy

Nutrition Management 2.0

A comprehensive, ESPEN guideline-driven approach that combines nutritional assessments with technological innovation to prevent feeding-related complications in critical care.

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  • Guided tube placement with continuous verification
  • Continuous metabolic assessment - REE
  • Optimal feeding plan and disease-specific nutrition
  • Real-time reflux and aspiration reduction
  • Automatic gastric residual evacuation
  • Feeding compensation
  • Automatic rinse & controlled bolus
  • Continuous urine flow detection and AKI alarms

Primary endpoint

Feeding efficacy (FE) achieved and deviation from 100% of FE

The primary endpoint was the average deviation from the daily feeding target, defined as mean 100× absolute value of (net nutrition delivered (mL) – volume to be delivered (VTBD; mL)/VTBD)% over all study days other than those when enteral feeding was stopped on medical order.

FE (%)
  • p < 0.0001
  • smART+
  • control
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Secondary endpoints

ICU LENGTH OF STAY

ICU length of stay was substantially reduced.

▼3.3 DAYS
HR 1.71, 95% CI: 1.13-2.60, p = 0.012 | adjusted

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time_graph

LENGTH OF VENTILATION

Length of ventilation was substantially reduced.

▼3.3 DAYS
HR 1.64, 95% CI: 1.08-2.51, p = 0.021 | adjusted

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Feeding efficacy categories

Categories represent deviations below and above target feeding efficiency. The difference in number of days are linked to the difference in length of stay.

% of days in category
  • smART+ (n = 313 days)
  • control (n = 462 days)
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0.9 < FE < 1.1
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0.8 < FE < 0.9 or 1.1 < FE < 1.2
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0.6 < FE < 0.8 or 1.2 < FE < 1.4
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0.6 < FE or FE > 1.4

Feeding efficacy throughout the trial

Patients in the smART+ group reached a feeding efficacy of 85% or more throughout the trial, while the control group reached between 60% and 70% of feeding efficacy.

FE %
  • smART+
  • control
Day 1–3
day1-3
Day 4–6
day4-6
Day 7–9
day7-9
Day 10
day10

Gastric residual volume (GRV): Average daily total and maximum amounts

The average daily total amount of GRV as well as the average maximum GRV amount are significantly higher in the control group vs. the smART+ group.

Average daily total GRV [ml] – ITT
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Average max GRV [ml] – ITT
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Reflux events and gastric function

One of the core functionalities of the smART+ Platform is achieving maximum feeding efficiency by detecting and responding to gastric intolerance in real time. Reflux events cannot be compared with those in the control group since the only solution on the market that can perform this function is the smART+ Platform. Notably, massive reflux events peaked on day 6, decreasing thereafter.

  • Massive reflux events (n)
  • Massive reflux duration (min)
reflux

Total daily feeding efficacy analysis

The control group stayed in ICU a total of 462 days, encountering underfeeding on most days and overfeeding on some days.

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ICU stay lasted for 313 days in the smART+ group, contrasting with 462 days in the control group – a notable difference of 148 days. The frequency of overfeeding and, especially, the extent of underfeeding were significantly improved compared to the control group.

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In the control group, ~100%* feeding efficiency was achieved in 22 days out of 462 days, amounting to just 5% of the treatment duration. In contrast, the smART+ group reached ~100% feeding efficiency in 162 days out of 313 days, constituting 52% of the treatment duration. This clearly demonstrates that the smART+ Platform is 10 times more efficient in attaining nutritional targets compared to the control.

*~100% FE: 0.98 ≤ FE ≤ 1.02

analysis_3

Conclusion

The smART+ Platform improved adherence to feeding goals and reduced ICU length of stay and length of ventilation versus standard of care in critically ill patients.

FEEDING
EFFICIENCY

89.5% VS 65.7%

p < 0.0001

REDUCTION IN
ICU LENGTH OF STAY

▼3.3 DAYS

From 13.7 days
to 10.4 days

REDUCTION IN
LENGTH OF VENTILATION

▼3.3 DAYS

From 12.8 days
to 9.5 days

See the study