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Search / Trial NCT04482556

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

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Pediatrics Indirect Calorimetry Enteral Nutrition Metabolism Critical Care

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.

About Boston Children's Hospital

Boston Children's Hospital is a leading pediatric healthcare institution renowned for its commitment to advancing child health through innovative research and exceptional clinical care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in pediatric medicine to conduct rigorous and ethically sound research studies aimed at improving treatment options and outcomes for children. With a collaborative approach that integrates cutting-edge technology and multidisciplinary teams, Boston Children's Hospital is dedicated to translating scientific discoveries into practical applications that enhance the well-being of young patients and their families.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Nilesh M Mehta, MD

Study Director

Boston Children's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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