Two prospective, observational, non-randomized clinical studies were conducted to demonstrate the accuracy and precision of Nellcor™ Respiration Rate Software (Version 2.0) using the Nellcor™ adult respiratory sensor.
The range of respiration rates observed in the studies was 4 to 32 breaths per minute. Accuracy was calculated using both root mean square difference (RMSD) and mean error. The results demonstrate that Nellcor Respiration Rate software calculates respiration rate with a mean error of less than one breath per minute when compared to respiration rate derived from the capnography-based reference.
|Population||N||Accuracy: RMSD (Breaths Per Minute||Accuracy: Mean Error (Breaths Per Minute)||Precision: Standard Deviation (Breaths Per Minute)|
|Healthy Volunteers||30||1.04||0.05||± 1.04|
|Hospital Patients||75||2.58||0.53||± 2.54|
|All Subjects||105||1.73||0.22||± 1.72|