RESUMO
Pulse oximetry is a standard of care during anaesthesia in high-income countries. However, 70% of operating environments in low- and middle-income countries have no pulse oximeter. The 'Lifebox' oximetry project set out to bridge this gap with an inexpensive oximeter meeting CE (European Conformity) and ISO (International Organization for Standardization) standards. To date, there are no performance-specific accuracy data on this instrument. The aim of this study was to establish whether the Lifebox pulse oximeter provides clinically reliable haemoglobin oxygen saturation (Sp O2 ) readings meeting USA Food and Drug Administration 510(k) standards. Using healthy volunteers, inspired oxygen fraction was adjusted to produce arterial haemoglobin oxygen saturation (Sa O2 ) readings between 71% and 100% measured with a multi-wavelength oximeter. Lifebox accuracy was expressed using bias (Sp O2 - Sa O2 ), precision (SD of the bias) and the root mean square error (Arms). Simultaneous readings of Sa O2 and Sp O2 in 57 subjects showed a mean (SD) bias of -0.41% (2.28%) and Arms 2.31%. The Lifebox pulse oximeter meets current USA Food and Drug Administration standards for accuracy, thus representing an inexpensive solution for patient monitoring without compromising standards.
Assuntos
Hipóxia/diagnóstico , Monitorização Fisiológica/instrumentação , Monitorização Fisiológica/normas , Oximetria/instrumentação , Oximetria/normas , Adulto , Feminino , Voluntários Saudáveis , Humanos , Hipóxia/sangue , Masculino , Monitorização Fisiológica/métodos , Oximetria/métodos , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: To determine the effects of temazepam on the quality of sleep and on oxygen saturation during sleep in subjects at high altitude. DESIGN: Randomised, blinded, crossover, placebo controlled trial. SETTING: Base camp at Mount Everest (altitude 5300 m). SUBJECTS: 11 members of British Mount Everest Medical Expedition recently arrived at base camp. INTERVENTION: Participants were randomly allocated to receive either temazepam 10 mg or placebo on their first night at base camp and the other treatment on the second night. MAIN OUTCOME MEASURES: Quality of sleep (assessed subjectively), mean arterial oxygen saturation value, and changes in saturation values (as measure of periodic breathing) while participants taking temazepam or placebo. RESULTS: All participants noted subjective improvements in sleep. Mean saturation value remained unchanged when temazepam was compared with placebo (74.65% v 75.70%, P = 0.5437). There were fewer changes in oxygen saturation when participants took temazepam and when measured as decreases > 4% below the mean value of saturation each hour (P = 0.0036, paired Student's t test (two tailed)). CONCLUSIONS: Participants taking temazepam at 5300 m showed no significant drop in mean oxygen saturation values during sleep. Both the number and severity of changes in saturation during sleep decreased and the quality of sleep improved. This may be a result of a reduction in the number of awakenings and might lead to greater respiratory stability and fewer episodes of periodic breathing. This has the effect of improving the quality of sleep and reducing the number of periods of desaturation during sleep.