Clinical usefulness of pulse oxi-capnometer, CapnoEye: a multicenter, non-randomized, open -label study for monitoring of EtCO2 in patients with respiratory disease. - Clinical usefulness of pulse oxi-capnometer, CapnoEye.

The correlation between PaCO2 measured by arterial blood gas analyzer invasively and EtCO2 measured by pulse oxi-capnometer, CapnoEye, which was investigational device was studied. - Sixty patients in total were enrolled, with age 67.4+/-14.1 (mean+/-SD), 37 (61.7%) males and 23 (38.3%) females. - Their primary diseases are COPD for 21 cases (35.0%), asthma 5 (8.3%), idiopathic interstitial pneumonia 13 (8.3%), and others 26 (43.3%). - Correlation coefficient between PaCO2 and EtCO2 for patients of per protocol set (PPS, n=59) was r=0.815 and its regression line formula was y=1.065x - 4.783 (95% CI 0.864 - 1.266) (p<0.001). - Sub-analysis for PPS showed that high level of correlation coefficient between PaCO2 and EtCO2 was observed in groups of gender, age, inpatient or outpatient, and various type of respiratory diseases. - The study also suggested that correlation between respiration rate and EtCO2 was not clear, and an appropriate pattern of breathing rhythm for each individual patient could effect the accuracy of CapnoEye. - No adverse event and malfunction was observed. - Usefulness of CapnoEye in various respiratory disease care would be expected not only for inpatient but also outpatient as home-care equipment.