Mechanical Ventilation Clinical Trial
Official title:
Comparison of the Q-NRG+ Indirect Calorimetry Device Versus the V(Max) Encore Device in Mechanically Ventilated Children
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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | In mechanically ventilated children, we will describe the mean bias and limits of agreement in measurements using both indirect calorimeters. Our hypothesis is that the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) with the 2 devices will have a low mean bias and will be within clinically acceptable limits of agreement. | 1 hour/participant | |
Primary | 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. | Total time lapsed, including time for patient data input, warm-up, calibration, and gas exchange measurements in steady state will be recorded. Our hypothesis is that the time required to obtain energy expenditure with Q-NRG+ device will be significantly shorter as compared to the Vmax Encore device. | 1 hour/participant |
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