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Nellcor™ Respiration Rate Technology Nellcor Respiration Rate software is a ™ breakthrough technology that may provide clinicians with an earlier indicator of evolving respiratory issues through the continuous monitoring of a patient’s respiratory rate with an economical, single, comfortable integrated sensor. “The methods we currently have available to monitor respiration rate are not always accurate, despite the fact that it is a critical vital sign. The Respiration Rate system from Covidien gives us a better picture of a patient’s overall respiratory status, does not change the workflow of our clinical staff and allows us to better provide effective treatment through a finger sensor that is familiar to clinicians and comfortable for patients.” Single Sensor Technology. Respiration Rate, SpO2 and Pulse Rate from One Sensor. Respiratory compromise is common, costly and deadly.1-4 Standards and guiding bodies recommend that patients should be continuously monitored. The Anesthesia Patient Safety Foundation (APSF) further recommends the use of multiple parameters, like pulse oximetry and respiration rate, to detect respiratory compromise before it progresses to respiratory failure.5 Nellcor™ Respiration Rate technology provides an assessment of your patients’ oxygenation and respiration rate trend through a single finger sensor. This technology delivers noninvasive, continuous monitoring of respiratory status. It also may provide an early warning of impending respiratory distress, so you may intervene early and possibly improve the safety and health of your patients. –Dr. Graham Douglas, Respiratory Unit, Aberdeen Royal Infirmary Examples of PM1000N-RR screen layouts Nellcor™ Respiration Rate Software is available as a software upgrade to the Nellcor™ Bedside Respiratory Patient Monitoring System, PM1000N. The Respiration Rate system is intended to be used for the continuous noninvasive monitoring of respiration rate for adult patients in hospitals and hospital-type facilities. The Respiration Rate software uses pulse oximetry technology, sensors and workflows to derive respiration rate based on the changes in the photoplethysmogram (pleth) waveform that occur as a result of breathing. Breathing causes changes in the cardiovascular, respiratory and autonomic nervous systems and results in changes in the pleth waveform. These modulations can be used to calculate respiration rate. Nellcor™ Respiration Rate complements SpO2, pulse rate and Saturation Pattern Detection (SPD) Alert to provide a more complete picture of a patient’s respiratory status. Using this information, clinicians may identify evolving respiratory compromise sooner and possibly intervene more quickly to potentially minimize the risk of dangerous respiratory events. Nellcor Respiration Rate Technology Features ™ • Provides a continuous, non-invasive measurement of respiration rate, SpO2 and pulse rate using a single sensor • Accuracy of ±1 breath per minute when compared to respiration rate derived from a capnography based reference • Works in parallel with Nellcor™ pulse oximetry, Saturation Pattern Detection (SPD) and SatSeconds Alarm Management System for a comprehensive respiratory monitoring solution • Nellcor™ Respiration Rate technology measures Breaths per Minute (BrPM) and may be an earlier indication of respiratory compromise compared to continuous SpO2 monitoring alone • Offered as a software upgrade to the Nellcor™ Bedside Respiratory Patient Monitoring System, PM1000N Clinical Studies** Two (2) prospective, observational, non-randomized clinical studies were conducted to demonstrate the accuracy of the Nellcor™ Respiration Rate Software (Version 2.0) using the Nellcor™ Adult Respiratory Sensor. One study 2 Specifications Measurement Range 4 to 40 breaths per minute Accuracy ± 1 breath per minute* Display/Indicators Respiration rate number (Breaths/min) Real time respiration rate trend data Alarms Audible and visual alarms for low and high respiration rate User modifiable lower respiration rate alarm limit at 8 breaths per minute User modifiable higher respiration rate alarm limit at 28 breaths per minute *Respiration rate accuracy is stated relative to a reference signal obtained from a etCO2 waveform. Accuracy of Respiration Rate was established using bench-top testing and clinical studies in 30 healthy volunteers and 75 hospitalized patients. Hospital studies were conducted using convenience sampling and did not necessarily include all patient conditions found in hospitals and hospital-type settings. These clinical study results may not generalize to all patient conditions. was performed with healthy volunteers while a second study enrolled a convenience sample of hospitalized study subjects. Accuracy was established by comparison to respiration rate determined from capnography waveforms. Methods Data from 105 enrolled subjects were included in the analysis, including 30 healthy volunteers and 75 hospitalized patients. Subjects were studied for approximately 30 minutes. Respiration rate was derived every five seconds using the Nellcor™ Respiration Rate Software and from manual counting of breaths on the capnograph waveforms by an anesthesiologist blinded to all other data (the “reference”). Study Population Demographics for study subjects are presented in Tables 1 and 2. TABLE 1. Demographics Healthy Demographics Mean ± Standard Deviation (Range) Age (Years) 32.9 ± 6.97 Gender (Male/Female) 17/13 Weight (kg) 79.0 ± 21.0 TABLE 2. Demographics Hospital Demographics Mean ± Standard Deviation (Range) Age (Years) 54.2 ± 17.2 Gender (Male/Female) 50/40* Weight (kg) 91.5 ± 26.3 *Of 90 subjects enrolled in the studies, 75 subjects yielded valid data. The 15 excluded subjects did not meet the predetermined data criteria for various reasons i.e. lack of a reliable reference signal, co-morbidity, arterial fibrillation. TABLE 3. Accuracy and Precision for Nellcor™ Respiration Rate Software versus 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 *Of 90 subjects enrolled in the studies, 75 subjects yielded valid data. The 15 excluded subjects did not meet the predetermined data criteria for various reasons i.e. lack of a reliable reference signal, co-morbidity, arterial fibrillation. Study Results Results for the Nellcor™ Respiration Rate Software are shown in Table 3. 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 the Nellcor™ Respiration Rate Software calculates respiration rate with a mean error of less than 1 breath per minute when compared to respiration rate derived from the capnography-based reference. Adverse Events No adverse events were reported during the studies. Conclusion In clinical studies of healthy subjects and hospitalized study subjects, the Nellcor Respiration Rate Software provided respiration rate with an accuracy of ± 1 breath per minute when compared to respiration rate derived from a capnography-based reference. Hospital study was conducted using convenience sampling and did not necessarily include all patient conditions found in hospitals and hospital-type settings. These clinical study results may not generalize to all patient conditions. The clinical studies yielded 68,112 paired observations between the Nellcor™ Respiration Rate Software and the capnography-based reference method. Figure 1 presents a Bland-Altman plot of paired observations in healthy study subjects. Figure 2 provides the Bland-Altman plot of paired observations of the hospitalized study subjects. HEALTHY SUBJECTS FIGURE 1. Modified Bland-Altman Plot of Nellcor™ Respiration Rate Software versus Reference in Healthy Subjects (Clinical Report 10127504B00) Modified Bland-Altman: Nellcor Respiration Rate vs. Clinician Overscored Respiration Rate 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Difference (Clinician Overscored Respiration Rate - Nellcor Respiration Rate, BrPM) 15 RMSD = 1.05 ME = -0.05 StDev = 1.05 TTFPRR = 33.43 % UpTime RR = 99.02% % UpTime SPO2 = 99.19% N = 44282 10 5 Upper 95% LoA 0 Mean Bias Lower 95% LoA -5 -10 -15 5 10 15 Clinician Overscored Respiration Rate (BrPM) 1. Difference (Clinician Overscored Respiration Rate - Nellcor Respiration Rate, BrPM) 20 2. Clinician Overscored Respiration Rate (BrPM) 25 3. Upper 95% LoA 4. Mean 5. Lower 95% LoA 3 Nellcor™ Respiration Rate System HOSPITAL STUDY SUBJECTS FIGURE 2. Modified Bland-Altman Plot of Nellcor™ Respiration Rate Software verses Reference in Hospital Subjects (Clinical Report 10126992D00) Modified Bland-Altman: Nellcor Respiration Rate vs. Clinician Overscored Respiration Rate 30 101 102 RMSD = 2.72 ME = -0.48 StDev = 2.68 TTFPRR = 48.37 % UpTime RR = 96.68% % UpTime SPO2 = 99.28% N = 16687 106 108 109 111 113 116 117 118 119 124 125 126 128 130 134 138 139 141 144 146 149 150 152 155 156 159 160 163 164 165 166 168 169 170 171 172 173 174 175 176 179 180 181 183 184 Difference (Clinician Overscored Respiration Rate - Nellcor Respiration Rate, BrPM) 107 20 10 Upper 95% LoA 0 Mean Bias Lower 95% LoA -10 -20 185 186 187 190 -30 5 10 15 20 Clinician Overscored Respiration Rate (BrPM) 1. Difference (Clinician Overscored Respiration Rate - Nellcor Respiration Rate, BrPM) 2. Clinician Overscored Respiration Rate (BrPM) 25 3. Upper 95% LoA 30 4. Mean 5. Lower 95% LoA * Includes all high risk patients **ClinicalTrials.gov NCT01804062. ClinicalTrials.gov NCT01837537 1. Linde-Zwirble WL, Bloom JD, Mecca RS, Hansell DM. Postoperative pulmonary complications in adult elective surgery patients in the US: severity, outcome and resources use. Crit Care Med. 2010;14: P210. 2. Agarwal SJ, Erslon MG, Bloom JD. Projected incidence and cost of respiratory failure, insufficiency and arrest in Medicare population, 2019. Abstract presented at Academy Health Congress, June 2011. 3. Wier LM, Henke R, Friedman B. Diagnostic Groups with Rapidly Increasing Costs, by Payer, 2001 -2007. Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality. Statistical Brief #91. June 2010. Available at: http://ww.hcup-us.ahrq.gov/reports/statbriefs/sb91.pdf 4. Kelley SD, Agarwal S, Parikh N, Erslon M, Morris P. Respiratory insufficiency, arrest and failure among medical patients on the general care floor. Crit Care Med. 2012;40(12):764. 5. Stoelting RK, Overdyk FJ. Conclusions and recommendations from June 8, 2011 conference on electronic monitoring strategies to detect drug-induced postoperative respiratory depression. APSF Announcements. Available at: http://www.apsf.org/initiatives.php?id=10. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2015 Covidien. 12-PM-0266(4) 2 6135 Gunbarrel Avenue • Boulder, CO 80301 • 800-635-5267 covidien.com/rms