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

NCT04482556 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-03

No results posted yet for this study

Summary

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).

Conditions

  • Calorimetry, Indirect
  • Oxygen Consumption
  • Metabolism
  • Mechanical Ventilation

Interventions

DEVICE

Q-NRG+ Indirect Calorimetry Device

The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.

DEVICE

V(max) Encore Indirect Calorimetry Device

The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.

Sponsors & Collaborators

Principal Investigators

  • Nilesh M Mehta, MD · Boston Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2024-12-01
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482556 on ClinicalTrials.gov