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 |