40 Participants Needed

Indirect Calorimetry Devices for Mechanically Ventilated Children

BD
NM
Overseen ByNilesh M Mehta, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

NM

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.
See 3 more

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Group I: V(max) Encore Indirect Calorimetry DeviceExperimental Treatment1 Intervention
Group II: Q-NRG+ Indirect Calorimetry DeviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+
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