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)

Trial Summary

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).

Research Team

NM

Nilesh M Mehta, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: V(max) Encore Indirect Calorimetry DeviceExperimental Treatment1 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 DeviceExperimental Treatment1 Intervention
Q-NRG+ device will be compared to current V(max) device in each enrolled patient in subsequent, alternating fashion.

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Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
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Recruited
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