Clinical trial NCT04098224: Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
Official title: Nutrition Monitoring and Feeding Optimization With the smART+ System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspiration Pneumonia
Malnutrition
Lead sponsor: ART Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Nutrition Optimization
timeFrame: 2 days-14 days
Secondary outcomes:
measure: Device Safety According to Occurrence or Absence of Related AE Adverse Event or SAE Serious Adverse Events
timeFrame: 2 days-14 days
measure: Decrease in Intensive Critical Unit Length of Stay
timeFrame: from admission to discharge from ICU ('ICU length of stay')
measure: Reduction of Number of Patients With VAE (Ventilation Associated Events)
timeFrame: 2 days-14 days
measure: Decrease in ICU Ventilation Days
timeFrame: from admission to discharge from ICU ('ICU length of stay') up to 14 days.
measure: Decrease in Workload Related to Nurse Gastric Residual Volume (GRV) Time
timeFrame: 2 days-14 days
measure: Assessment of Urine Flow Monitoring Related to Patient Condition
timeFrame: 2 days-14 days
measure: Convenience of Use of the System and the User Interface (by Subjective Staff Questionnaire)
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Beilinson Hospital
state: Isreal
Study officials:
affiliation: Beilinson Hospital
name: Ilya Kagan, MD
role: PRINCIPAL_INVESTIGATOR
References: