Comparative Evaluation of smART+ REE Module to an FDA-cleared Device, for REE Calculation in ICU Patients

NCT07165080 | Completed FDA Device

• 1 other identifier: CRO-J-3356
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single-center, comparative evaluation of smART+ REE Module to an FDA-cleared REE Module device, for REE calculation in ICU Patients.

Conditions

Comparative Study; REE; Resting Energy Expenditure

Keywords

Comparative; ICU; REE; COSMED; VCO2

Outcome Measures

Primary Outcomes (1)

• Compare the resting energy expenditure (REE) calculations obtained with the smART+ REE Module and those obtained with the Q-NRG+ Portable Metabolic Monitor by COSMED (K190800)

  Compare the resting energy expenditure (REE) calculations obtained with the smART+ REE Module and those obtained with the Q-NRG+ Portable Metabolic Monitor by COSMED (K190800), using the root mean squared error (RMSE). The assessment of differences is intended to validate the smART+ REE Module's accuracy when compared to an FDA-cleared device that is representative of "gold standard" measurement for the same purpose.

  From enrollment until the discharge from the ICU, approximately within 4 days.

Secondary Outcomes (2)

• Compare the REE measurements obtained with the smART+ and those obtained with the Q-NRG+ Portable Metabolic Monitor, using the relative error (RE).

  From enrollment until the discharge from the ICU, approximately within 4 days.

• Compare the VCO2 measurements obtained with the smART+ and those obtained with the Q-NRG+ Portable Metabolic Monitor, using the relative error (RE).

  From enrollment until the discharge from the ICU, approximately within 4 days.

Other Outcomes (1)

• Exploratory Endpoint

  From enrollment until the discharge from the ICU, approximately within 4 days.

Study Arms (1)

All participants

The two study devices will be used simultaneously: the patient's respiratory equipment will be connected directly to the smART+ REE module, and then the COSMED Q-NRG+ will be connected just downstream of that.

Device: smART+ REE

Interventions

smART+ REE DEVICE

The two study devices will be used simultaneously: the patient's respiratory equipment will be connected directly to the smART+ REE module, and then the COSMED Q-NRG+ will be connected just downstream of that. See the diagram and key below:

All participants

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Due to the anticipated dropout rate after one or two measurement rounds, we plan to recruit a minimum of 25 patients and up to 40 patients. Each patient will undergo a maximum of 4 measurement rounds. The study will conclude once 90 measurement rounds have been completed, regardless of the number of patients remaining in the study at that point. All patients enrolled in the study will be mechanically ventilated patients who have already been admitted to the ICU, are eligible for use of the smART+ System and COSMED device, are in a relatively stable condition, and are expected to remain ventilated for at least 24 hours. The study will exclude patients requiring chest drainage, because not all the air exhaled by these patients comes through the ventilator tube (due to the drains collecting air leak), compromising the accuracy of VCO2 measurements.

You may qualify if:

• Males and females 22 years or older
• Patient has already been admitted to ICU
• Patient expected to be ventilated at least 24 hours after enrollment
• Patients should be stable hemodynamically (no increase/decrease in vasopressors) and respiratory (no change in mechanical ventilation settings) for at least 1 hour prior to initiation of study procedures.

You may not qualify if:

• Women who are pregnant
• Patient requiring chest drainage

Sponsors & Collaborators

• ART Medical Ltd.: lead

Study Sites (1)

Beilinson Medical Center

Petah Tikva, Hasharon, Israel

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: September 10, 2025
• Study Start: August 12, 2025
• Primary Completion: October 21, 2025
• Study Completion: October 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

IL (1)