Comparison of the Q-NRG+ Indirect Calorimetry Device Versus the V(Max) Encore Device in Mechanically Ventilated Children

Launched by BOSTON CHILDREN'S HOSPITAL · Jul 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two different devices that measure how much oxygen children use and carbon dioxide they produce while they are on a breathing machine (mechanically ventilated). Researchers want to see if the new Q-NRG+ device gives results that are similar to the standard device, called the V(max) Encore, which is already used in hospitals. This is important because accurate measurements can help doctors better understand how well a child's body is functioning while they are being supported by a ventilator.

To participate in this study, children must be over 10 years old, weigh more than 10 kilograms (about 22 pounds), and be receiving certain types of mechanical ventilation with specific settings. They should also be stable enough to be part of the study, meaning they are not facing severe medical issues that could complicate their care. If eligible, participants will have their oxygen and carbon dioxide levels measured using both devices during their hospital stay. This study aims to ensure that the new device is safe and effective for use in young patients needing respiratory support.

Gender

ALL

Eligibility 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.