CO2 MEASUREMENTS WITH THE CAPNOVUE M1 ARE SIGNIFICANTLY MORE CONSISTENT THAN WITH A “JERRY-RIGGED” DEVICE Monitoring exhaled CO2 (capnography) of spontaneously breathing sedated patients is the standard of care for anesthesiologists in the US1, UK2, and Canada3. Accurate and consistent CO2 measurements provide the optimal information to guide clinician decision making. Each component of the capnography system, from gas analyzer to oxygen face mask, contributes to the accuracy of measured results. The assembly of “jerry-rigged” devices is not standardized in any way by anesthesia groups, professional societies, or the FDA. In many cases the IV catheter attached to the gas sample line will have a smaller cross sectional lumen than the sample line itself, thus increasing resistance to gas flow within the monitoring system. Capnography utilizes continuous sampling of gas near the patient’s nose and mouth to measure CO2 levels over time. During exhalation, CO2 levels rise and during inhalation, CO2 levels fall. Rising and falling levels of CO2 create a waveform on the capnograph that can guide clinical intervention in real time. Changes to the size and shape of CO2 waves correspond to respiratory alterations and demand immediate assessment. The CapnoVue M1 (manufactured by Monitor Mask Inc., Seattle, Washington) is a face mask designed specifically for use in the operating room and is cleared by the FDA for face mask capnography. The CapnoVue M1 features two integrated CO2 sampling ports encircled by gas exhalation vents on the lateral surfaces of the mask that enable direct connection of the CO2 sample line (Figure 2). The CapnoVue M1 requires no assembly and has a standardized manufactured design. Face Mask Comparison Figure 2: The CapnoVue M1 In this study, measured exhaled CO2 (etCO2) levels of spontaneously breathing subjects were assessed using two devices; a "jerry-rigged" oxygen face mask and the CapnoVue M1. "Jerry-rigged" devices are used by anesthesiologists in the vast majority of face mask capnography cases and are not cleared or regulated by the FDA. Most often, these devices are assembled by the off-label process of sticking an IV catheter through a gas vent or wall of an oxygen mask to attach a gas sample line (Figure 1). Figure 1: A “jerry-rigged” face mask CO2 monitor sample line attached CO2 Measurement Results In the current study, etCO2 measurements with a "jerry-rigged" mask and a CapnoVue M1 device were assessed. The data was collected on five subjects for both nose and mouth breathing with an oxygen inflow rate of six liters per minute. The "jerry-rigged" mask testing results include three etCO2 sample locations due to non-standardized assembly and numerous sample location possibilities. For example, when an IV catheter is used to attach the sample line to the mask (Figure 1), the tip of that catheter may be located in a number of positions. It is additionally possible that the catheter may begin in one position and then move to another during the patient’s clinical course due to the instability of assembly. In this study we assessed etCO2 levels during nose and mouth breathing (Figure 3) at three potential catheter tip locations within the “jerry-rigged” mask: 1. 2. 3. strong correlation for nose and mouth breathing etCO2 levels. Figure 4: Nose and mouth breathing mean etCO2 levels in mmHg with the CapnoVue M1 Less than 1 cm from the nose Less than 1 cm from the mouth Less than 1 cm from the oxygen inflow The “jerry-rigged” mean testing results demonstrate significant inconsistency. Physiology dictates that an individual patient will have one arterial CO2 level at any moment in time but “jerry-rigged” masks show marked variability of etCO2 measurements. Figure 3: Nose and mouth breathing mean etCO2 levels in mmHg with a “jerry-rigged” face mask at three sample locations Summary CO2 Measurements with the CapnoVue M1 are significantly more consistent than with a “jerry-rigged” device. etCO2 levels obtained with “jerry-rigged” devices vary significantly by sample location and whether nose or mouth breathing is occurring. etCO2 measurements obtained by the CapnoVue M1 are highly consistent with minimal difference observed between nose and mouth breathing. The CapnoVue M1 provides fixed, standardized locations for etCO2 measurement with two integrated CO2 sampling ports. The ports are in mirror image locations on opposite sides of the mask midline and provide equivalent gas sampling results as confirmed with bench testing during the FDA clearance process. During clinical use, the anesthesia provider will choose to use one of the two ports for etCO2 monitoring based upon the specific clinical scenario. As in clinical care, this study measured etCO2 levels during nose and mouth breathing (Figure 4) by connecting a capnograph to one of the two integrated CO2 monitoring ports. Monitoring etCO2 with the CapnoVue M1 yields highly consistent, nearly singular, etCO2 levels analogous to the patient’s unique arterial CO2 level. Furthermore, the CapnoVue M1 mean testing results demonstrate a Fluctuating etCO2 levels with the “jerry-rigged” mask that do not correspond to changes in a patient’s clinical condition may lead clinicians to place less value on etCO2 monitoring and slow response times to actual changes in respiratory status. Consistent etCO2 results, such as those from the CapnoVue M1, more clearly identify changes in clinical status, increase the value of etCO2 monitoring for the clinician, and optimize response times to respiratory alterations. When compared to a common “jerry-rigged” face mask, the CapnoVue M1provides significantly more consistent etCO2 measurements with closely correlated nose and mouth breathing etCO2 levels. References 1. American Society of Anesthesiologists, "Standards for Basic Anesthetic Monitoring," 2011. 2. Association of Anaesthetists of Great Britain and Ireland, "The use of capnography outside of the operating theatre," 2011. 3. Canadian Anesthesiologists' Society, "Guidelines To The Practice of Anesthesia," 2012. COPYRIGHT © 2016 MONITOR MASK INC. ALL RIGHTS RESERVED. www.MonitorMask.com [email protected] Monitor Mask Inc., Bellevue, WA 600010 Rev 1 .
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