220 | Chapter 9 Feasibility criteria To explore the feasibility of this CPET set-up in laryngectomized patients, a priori criteria were set, based on literature and consensus in the research team, each of which had to be satisfied: 1. The connector is not leaking air during the measurements 2. Subjects are not complaining about discomfort using the connector with an adhesive baseplate and HME 3. No occurrence of (serious) adverse events, such as hyperventilation, dyspnea, ECG abnormalities, collapse, etc. 4. At least 80% of the patients are able to reach a Respiratory Exchange Ratio*>1.1 (RER=VCO2/VO2) and/or 95% of their predicted maximum heart rate in at least one of the tests27,28 * Respiratory exchange ratio (RER) = the ratio between the metabolic production of carbon dioxide (VCO2) and the uptake of oxygen (VO2) Data from CPET Variables of interest were Time in Test, Peak Workload (Wpeak), Heart Rate (heartbeats per minute), Perceived level of exertion (Borg-score; score ranges from 6 till 20 in which a higher score resembles a higher perceived effort), peak oxygen uptake (VO2 peak) both absolute (L/min) and relative to body weight (ml/kg/min), RER, anaerobic threshold (VO2/kg) and ventilatory efficiency expressed as minute ventilation/carbon dioxide production at anaerobic threshold (VE/VCO2). All data were calculated for the total group as well as for the subgroups based on regularly used HME type (0.3 or 0.6 hPa), and HME used during the test (regular or lowest resistance). We used graphs to plot outcomes for the 0.15 hPa HME (Energy) against those obtained with patients’ regular (Go or Home) HME. Statistical analysis All data was analyzed using IBM SPSS statistics 27 and Graphpad Prism 9. Since this was an exploratory study with a small sample size, we did not statistically test the differences for significance, but rather provide descriptive analyses and visual displays of patient data. Ethical considerations The authors declare that all procedures contributing to this work are performed in accordance with the ethical standards of the medical ethical review committee of the Netherlands Cancer Institute who approved the study (registration nr. NL72840.031.20), and with the Helsinki Declaration of 1975, as revised in 2008.
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