Accuracy of Oxygen Consumption and Carbon Dioxide Elimination Measurements in 2 Breath-by-Breath Devices

Area of Science:

• Pediatric critical care
• Respiratory physiology
• Medical device evaluation

Background:

• Accurate quantification of oxygen consumption (V̇_O) and carbon dioxide elimination (V̇_CO) is vital for assessing nutritional and hemodynamic status in patients.
• Limited availability of accurate devices for measuring these parameters in pediatric populations necessitates evaluation of existing technologies.

Purpose of the Study:

• To assess the accuracy and agreement of two commercial respiratory modules for measuring V̇_O and V̇_CO in a pediatric in vitro model.
• To determine the clinical applicability of these devices for pediatric patient monitoring.

Main Methods:

• Utilized a Huszczuk simulation model to generate controlled V̇_O and V̇_CO values (20-100 mL/min) representative of pediatric patients.
• Evaluated two FDA-cleared respiratory modules: E-COVX and E-sCAiOVX-00.
• Employed Bland-Altman analysis to quantify bias and limits of agreement for each device against simulated gas exchange values.

Main Results:

• The E-COVX module exhibited significant bias, with mean percentage errors of -26.3% for V̇_O and -39.3% for V̇_CO, deemed clinically unacceptable.
• The E-sCAiOVX-00 module demonstrated acceptable accuracy, showing a mean bias of -0.5% for V̇_O and -6.0% for V̇_CO.
• The E-sCAiOVX-00 module's acceptable performance was observed for V̇_O and V̇_CO ranges of 40-100 mL/min, corresponding to pediatric patients weighing approximately 5-16 kg.

Conclusions:

• The E-COVX module is not recommended for use in pediatric patients due to unacceptable measurement bias.
• The E-sCAiOVX module provides clinically acceptable accuracy for V̇_O and V̇_CO measurements in pediatric patients within the 5-16 kg weight range.
• This study validates the E-sCAiOVX module as a reliable tool for respiratory gas exchange monitoring in specific pediatric populations.