Aspiration PneumoniaNCT04098224
Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study
A study testing smART+ System in people with Aspiration Pneumonia and Malnutrition, run by ART Medical Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonia, Malnutrition
- What is being tested?
- smART+ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Jan 2020to 7 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Aspiration Pneumonia, Malnutrition
- Being tested
- smART+ System
- Medical subject headings
- Pneumonia, Aspiration, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smART+ SystemDevice
Utilizing the smART+ System to provide feeding optimization to the patient
| Study group | Role | What they receive |
|---|---|---|
| Interventional Device - Treated | Experimental | Subjects connected to the investigational device smART+ Receives: Device: smART+ System |
| Control Group | No intervention | treated according to local Standard of Care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 2 days-14 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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]
Measured: 2 days-14 days
Decrease in ICU Ventilation Days
Evaluated by the number of hours of End-tidal CO2 from the hospital electronic records
Measured: 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.
Measured: 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
Measured: 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).
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start12 Jan 2020
- Primary completion10 Mar 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilya Kagan, MD, Principal investigator, Beilinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098224
- Sponsor's protocol ID
- CRO-C-2822
- Status last verified
- May 2025
- First submitted
- 19 Sep 2019
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37480797
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Monitoring and Feeding Optimization With the smART+ System
- ClinicalTrials.gov ID
- NCT04098224
- Acronym / sponsor ID
- CRO-C-2822
- Conditions
- Aspiration Pneumonia, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ART Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Device - Treated | Experimental | Device: smART+ SystemSubjects connected to the investigational device smART+ |
| Control Group | No intervention | –treated according to local Standard of Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smART+ SystemUtilizing the smART+ System to provide feeding optimization to the patient | Device | Interventional Device - Treated |
Primary outcome
Nutrition Optimization
Time frame: 2 days-14 days
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))
7 secondary outcomes
Device Safety According to Occurrence or Absence of Related AE Adverse Event or SAE Serious Adverse Events
Time frame: 2 days-14 days
Decrease in Intensive Critical Unit Length of Stay
Time frame: from admission to discharge from ICU ('ICU length of stay')
Reduction of Number of Patients With VAE (Ventilation Associated Events)
Time frame: 2 days-14 days
Decrease in ICU Ventilation Days
Time frame: 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
Time frame: 2 days-14 days
Assessment of Urine Flow Monitoring Related to Patient Condition
Time frame: 2 days-14 days
Convenience of Use of the System and the User Interface (by Subjective Staff Questionnaire)
Time frame: Throughout the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37480797Kagan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Kagan, MD principal investigator
Beilinson Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smART+ System in people with Aspiration Pneumonia and Malnutrition, run by ART Medical Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition Optimization (time frame: 2 days-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.