Comparing two devices for measuring energy expenditure in ventilated children
Comparison of the Q-NRG+ Indirect Calorimetry Device Versus the V(Max) Encore Device in Mechanically Ventilated Children
NA · Boston Children's Hospital · NCT04482556
This study is testing two different devices to see which one better measures how much energy ventilated children are using to help doctors give them the right amount of nutrition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04482556 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and accuracy of the Q-NRG+ indirect calorimetry device compared to the Vmax Encore device in children who are mechanically ventilated. The research will involve alternating the use of both devices on enrolled patients to measure their oxygen consumption and carbon dioxide production. The Q-NRG+ device is designed to be more efficient and user-friendly, potentially overcoming limitations of existing indirect calorimetry methods. By providing reliable and quick measurements, this study seeks to improve individualized energy prescriptions for critically ill pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children over 10 years old, weighing more than 10 kg, who are mechanically ventilated and meet specific respiratory criteria.
Not a fit: Patients with hemodynamic instability, those requiring ECMO support, or undergoing end-of-life care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability of clinicians to provide tailored nutritional support to mechanically ventilated children.
How similar studies have performed: While indirect calorimetry has been widely used in adults, this specific approach with the Q-NRG+ device in pediatric patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children mechanically ventilated with endotracheal tube of tracheostomy in standard ventilatory modes such as SIMV-PC, SIMV-VC or PRVC * Age \> 10 years AND weight \> 10kg * FIO2 \< 60% * PEEP \< 8 * ETT leak \< 10% * The attending physician of record plans to order indirect calorimetry and considers research activity safe Exclusion Criteria: * Hemodynamic instability (hypotension according to PALS/ACLS formula or requiring 2 or greater vasoactive infusions) * Presence of chest tubes with ongoing air leak * Patients requiring ECMO support * Patients undergoing end-of-life care * Primary provider declines enrollment.
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Ben D Albert, MD
- Email: ben.albert@childrens.harvard.edu
- Phone: 617-355-7327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Calorimetry, Indirect, Oxygen Consumption, Metabolism, Mechanical Ventilation, Pediatrics, Indirect Calorimetry, Enteral Nutrition, Critical Care