Indirect Calorimetry Devices for Mechanically Ventilated Children

N/A

Recruiting

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 10 years AND weight > 10kg

PEEP < 8

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour/participant

Awards & highlights

Study Summary

This trial will compare the Q-NRG+ indirect calorimetry device to the Vmax Encore indirect calorimetry device to see if they provide similar minute-to-minute measurements of oxygen consumption and carbon dioxide production.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring devices, there are minimal expected side effects related directly to the use of these devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My breathing support settings are low.

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My child is on a ventilator through a tube or tracheostomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour/participant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour/participant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour/participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Calculated total testing time, including calibration, required to complete a steady state indirect calorimetry measurement using the Q-NRG+ device and the V(max) Encore.

Mean bias and limits of agreement between measured oxygen consumption (VO2) and carbon dioxide elimination (VCO2) in mechanically ventilated children assessed using the Q-NRG+ indirect calorimetry device and the V(max) Encore indirect calorimetry device.

Trial Design

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.

0 / 3Eligibility criteria met