Download Nellcor™ Respiration Rate Technology

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
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4
5
6
7
8
9
10
11
12
13
14
15
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25
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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
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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.
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