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?

The overarching aim of this proposal is to examine the feasibility of the Q-NRG+ indirect calorimetry device and its agreement with (Vmax) Encore indirect calorimetry device in mechanically ventilated children. 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 that are in agreement with those obtained by the standard indirect calorimetry device currently used at our institution (Vmax Encore).

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+