Indirect Calorimetry Devices for Mechanically Ventilated Children

Overseen By Nilesh M Mehta, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Hemodynamic instability, ECMO, end-of-life care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two devices that measure breathing in children on ventilators. The goal is to determine if the new device, Q-NRG+ (an indirect calorimetry device), provides results similar to the standard device, Vmax Encore, in tracking oxygen and carbon dioxide levels. The study seeks children on ventilators with specific settings, excluding those with complications like unstable blood pressure or chest air leaks. This trial could enhance how doctors monitor and care for ventilated children. As an unphased trial, it offers a unique opportunity to advance pediatric care technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that these indirect calorimetry devices are safe for mechanically ventilated children?

Research has shown that the Q-NRG+ device is safe for both adults and children, whether breathing independently or using a ventilator. The FDA has cleared the device, confirming it meets U.S. safety standards. Available studies have reported no specific side effects.

For the V(max) Encore device, research has confirmed its safe use in critically ill children on ventilators. These studies demonstrated that it accurately measures energy needs without causing harm.

Both devices are non-invasive, requiring no surgery or insertion into the body, which reduces risks. Overall, both devices are well-tolerated and proven safe for measuring energy needs in ventilated children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to compare two indirect calorimetry devices, the Q-NRG+ and the V(max) Encore, for use in mechanically ventilated children. Indirect calorimetry is a method used to accurately measure a patient's energy expenditure, which is crucial for tailoring nutritional support. The Q-NRG+ device is particularly interesting because it is designed to be more portable and user-friendly compared to the standard V(max) Encore device. By alternating the use of these devices in each patient, the trial hopes to determine if the Q-NRG+ can offer more precise or convenient measurements, potentially improving care for these young patients.

What evidence suggests that these indirect calorimetry devices are effective for mechanically ventilated children?

This trial will compare two devices for measuring energy needs in mechanically ventilated children: the Q-NRG+ Indirect Calorimetry Device and the V(max) Encore Indirect Calorimetry Device. Research has shown that the Q-NRG+ device effectively measures the energy needs of patients on ventilators. It provides real-time information on oxygen consumption and carbon dioxide production, aiding in understanding patient metabolism. Studies have found that this device works well for both adults and children, making it highly adaptable.

The V(max) Encore device, already widely used, has proven accurate for various levels of metabolic activity. It serves as the current standard for measuring similar metabolic markers in critically ill patients. Both devices aim to provide precise information on a patient's energy use, which can assist in customizing nutritional support. Participants in this trial will have their energy needs assessed using both devices in an alternating sequence. ^{1 4 5 6 7}

Who Is on the Research Team?

Nilesh M Mehta, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children over 10 years old and weighing more than 10kg who are on mechanical ventilation with specific settings. They must not have severe lung leaks, be unstable in their blood pressure, or be receiving end-of-life care.

Inclusion Criteria

ETT leak < 10%

My doctor plans to measure my metabolism and believes research is safe for me.

I am older than 10 years and weigh more than 10kg.

Exclusion Criteria

I currently have a chest tube due to an air leak.

My primary doctor has not approved me joining the trial.

I do not have severe low blood pressure or need multiple medications to increase my blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

Testing of the Q-NRG+ and V(max) Encore devices in an alternating fashion for each enrolled patient

1 hour/participant

1 visit (in-person)

Data Analysis

Data collected from the devices is analyzed for mean bias and limits of agreement

1-2 weeks

Follow-up

Participants are monitored for any adverse effects and data is reviewed with the clinical team

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Q-NRG+ Indirect Calorimetry Device
• V(max) Encore Indirect Calorimetry Device

Trial Overview The study is testing the Q-NRG+ device against the standard V(max) Encore device to measure oxygen consumption and carbon dioxide production in ventilated children to see if they agree on results.

How Is the Trial Designed?

Group I: V(max) Encore Indirect Calorimetry Device Experimental Treatment 1 Intervention

V(max) Encore device, currently institution's standard device, will be compared to Q-NRG+ device in each enrolled patient in subsequent, alternating fashion.

Group II: Q-NRG+ Indirect Calorimetry Device Experimental Treatment 1 Intervention

Q-NRG+ device will be compared to current V(max) device in each enrolled patient in subsequent, alternating fashion.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Citations

1. cosmed.com cosmed.com/en/products/indirect-calorimetry/q-nrg-plus

Q-NRG+ Q-NRG+ is the metabolic monitor intended for Energy Expenditure measurement on mechanically ventilated patients and spontaneously breathing subjects.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39208718/

The usefulness of a new indirect calorimeter in critically ill ... Results: Indirect calorimetric measurements were performed in 180 of the 432 admitted patients (42%). Of the 276 performed measurements 85% were valid, and of ...

3. baxter.com baxter.com/baxter-newsroom/baxter-and-cosmed-announce-us-fda-510k-clearance-q-nrg-indirect-calorimetry-device

Baxter and COSMED Announce U.S. FDA 510(k) ... Q-NRG+ can be used to test both adult and pediatric patients, as well as spontaneously breathing or mechanically ventilated patients.

4. withpower.com withpower.com/trial/phase-10-2020-11cb1

Indirect Calorimetry Devices for Mechanically Ventilated ... The overall hypothesis of this study is that the Q-NRG+ will provide minute-to-minute oxygen consumption (VO2) and carbon dioxide production (CO2) measurements ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405457724012646

How to interpret and apply the results of indirect calorimetry ... The present paper aims at providing clinical examples of the use of a contemporary IC device (Q-NRG ®, Cosmed, Italy), to show how teams with training apply and ...

6. emeaclinicalnutrition.baxter.com emeaclinicalnutrition.baxter.com/q-nrg

Q-NRG+ - Clinical Nutrition EMEA - Baxter Q-NRG+ offers quick and accurate resting energy expenditure (REE) measurement through indirect calorimetry (IC).

7. portalimages.blob.core.windows.net portalimages.blob.core.windows.net/products/pdfs/lnt1lacj_Brochure-Q-NRG+.pdf

Q-NRG™+ - NET Real Time dashboard of Ventilator test shows metabolic and ventilatory data as well as widgets to verify. Quality Control and understand ...