The tolerability and level of discomfort of 15 lpm vs 6 lpm oxygen through a normal nasal cannula

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Objectives: To determine the tolerability and level of discomfort from higher flow, non-humidified oxygen through a normal nasal cannula (NC) in healthy volunteers. Background Although high-flow non-humidified nasal oxygen at rates of up to 15 lpm is now recommended as a method to provide apneic oxygenation during intubation, many older sources suggest that flow-rates greater than 6 lpm can cause patient discomfort. , , To our knowledge, there is no evidence on the ability of subjects to tolerate high-flow NC and this trial will be the first research that evaluates the ability of subjects tolerate high-flow nasal oxygen through a normal NC. Methods: This prospective, double blinded, interventional, non-inferiority crossover study will be conducted in the Emergency Department (ED), Middlemore Hospital from December 2013 to June 2014. Subjects will be randomized and blinded to first receive either low-flow (6 lpm), or high-flow (15 lpm) of oxygen through NC for a maximum of 10-minutes (completion) or until the subject deems it intolerable. After at least a 1-hour washout period, subjects will then trial the alternative flow-rate. Populations The potential subjects include staff members working in Middlemore Hospital. No patients will be enrolled. The exclusion criteria will be previous participation in study, recent history of nasal trauma, or history of significant respiratory disease. Results The primary outcome will be the subject’s ability to tolerate each flow-rate at ten minutes. We believe 100% of subjects will tolerate 10-mintues of the low-flow NC and that no less than 90% will tolerate 10-minutes of high-flow NC. Other outcomes will be the difference in duration that the subject tolerates the NC as measured in seconds before the subject removes the NC. We hypothesize there will be less than one minute of difference between the flow-rates. Another outcome will be the subject’s discomfort as reported on a 100mm visual analog scale at each flow rate. A difference of 17mm will be considered clinically significant. We believe there will be a clinically significant difference of greater than 17mm between the two flow-rates. Other recorded outcomes will include the vital signs, symptoms of discomfort, and a description of a brief nasal exam on subjects reporting significant symptoms. We believe that there will be minimal differences in these other variables. Conclusions We predict that most subjects will be able to tolerate 10-minutes of high-flow nasal oxygen without meaningful discomfort.

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