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Medtronic / Covidien Products / Pulse Oximetry / Nellcor™ Respiration Rate Software / Clinical Indications

Clinical Studies

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.

Respiration Rate Accuracy
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
Respiration Rate Accuracy
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

Modified Bland-Altman Chart

Nellcor™ Respiration Rate vs clinician overscored respiration rate.
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