1. Rainbow Acoustic Monitoring

2. RAM Overview Respiration Rate and Pulse Oximetry Methods
Acoustic Respiration Rate (RRa)
RRa Accuracy
RRa Testimonials
Clinical Samples

3. Respiration Rate (RR): A Complement to Pulse Oximetry
Oxygen saturation is affected by
Breathing rate and depth
Lung function
Heart function
Relationship of RR to oxygen saturation
Very low respiration rate can lead to oxygen desaturation
Oxygen desaturation also caused by things other than low respiration rate
Benefit of respiration rate monitoring – in addition to pulse oximetry - may be even greater when patient is on supplemental oxygen
A more comprehensive assessment of the patient includes:
Oxygenation
Ventilation
Circulation

4. Respiration Rate Respiration Depression Narcotic Induced Apnea
PCA Pumps
Epidural Narcotics
Oral Narcotics
Obstructive Sleep Apnea (OSA)
Neurologic Disorders
Induce Central Apnea
Increased Respiration
Tachypnea
1st sign of metabolic decompensation
Early indicator of physiologic instability
The importance of respiratory rate monitoring can be viewed in two regions of clinical concerns, low respirator rates, and high respiratory rates
Low respiratory rates are a sign of respiratory depression, often the cause of over sedation with opioid narcotics, underlying disease states such as OSA or neurologic disorders that blunt the brain’s compensatory response to inadequate ventilation. The combination of OSA and use of opioids is a potentially dangerous combination on general care floors.
High respiratory rates place patients under extreme physiology stress. Rates over 25 breaths per minute are hard for patients to sustain for a prolonged period of time. Respiratory rates climbing from normal breathing patterns can be an early sign of the patient’s physiology struggling to compensate for abnormal states such as sepsis.
There is mounting research evidence that high respiratory rates and pulse rates are the earliest indicators that a patient is approaching potentially fatal cardiopulmonary events. Early detection is necessary to avoid such situations.
Ref: H. Gao, et al. Systematic review and evaluation of physiologic track and trigger warning systems for identification at-risk patients on the ward. Intensive Care Med (2007) 33:
D.R. Goldhill, S.A. White, and A. Sumner Physiological values and procedures in the 24 h before ICU admission from the ward, Anesthesia, 1999, 54,
D.R. Goldhill, A.F. McNarry. Physiological abnormalities in early warning scores are related to mortality in adult patients. British Journal of Anesthesia, 92 (6): (2004)
JP McFaddent, RC Price, et al. Raised respiratory rate in elderly patients: a valuable physical sign. British Medical Journal 1982 vol 284, 626-7

5. Current Respiration Rate Methods
Physical assessment (intermittent)
Transthoracic impedance (continuous)
Requires monitor and ECG electrodes
As chest expands impedance changes
Respiration rate measured from cyclical changes in impedance
No capital or increased sensor price (if already ECG monitoring)
Capnography (continuous)
Direct monitoring of the inhaled and exhaled concentration or partial pressure of CO2 using sensor mask or nasal cannula
Respiration rate measured by CO2 waveform analysis
Shape of waveform can provide additional information
Capital price is ~ $3K, sensor is $10-$15 per use

6. Recommendations: Post-Surgical Patient Monitoring
The combination of patient-controlled analgesia and lower staff-to-patient ratios on the general floor make it less likely that a clinician will be there to observe an avoidable adverse event.
The Anesthesia Patient Safety Foundation Recommends:
“continuous monitoring of oxygenation (pulse oximetry) and ventilation in non-ventilated patients receiving PCA, neuraxial opioids, or serial doses of parenteral opiods”
“It is critical that any monitoring system be linked to a reliable process to summon a competent health care professional to the patient’s bedside in a timely manner.”
Weinger MB. Dangers of Postoperative Opioids: APSF Workshop and White paper address prevention of postoperative respiratory complications. APSF Newsletter, 2006;21:61–7.

7. Respiration Rate Monitoring
Respiration rate is a critical vital sign that provides early detection of respiratory compromise and patient distress
Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia (PCA) for pain management as the sedation can induce respiratory depression and place patients at considerable risk of serious injury or death1-5
Although the Anesthesia Patient Safety Foundation (APSF) guidelines include oxygenation and ventilation monitoring in all patients receiving opioids,6 current methods for respiration rate monitoring can be limited by reliability or patient tolerance of nasal cannula
1 Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert: Patient controlled analgesia by proxy. Chicago: JCAHO, 2004
2 Institute for Safe Medication Practice. Safety issues with patient-controlled analgesia: Part I How errors occur. Huntingdon Valley: ISMP, 2003
3 Institute for Safe Medication Practices. Safety issues with patient-controlled analgesia: Part II How to prevent errors. Huntingdon Valley: ISMP, 2003
4 Bird M. Acute pain management: a new area of liability for anesthesiologists ASA Newsletter. Park Ridge: American Society of Anesthesiologists, 2007
5 Weinger MB. Dangers of Postoperative Opioids: APSF Workshop and White paper address prevention of postoperative respiratory complications. APSF Newsletter, 2006
6 Stoelting RK, Weinger MB. Dangers of Postoperative OpioidsﾑIs There a Cure? APSF Newsletter, 2009

8. Acoustic Respiration Rate (RRa)
When used with other clinical variables, first-ever continuous and noninvasive monitoring of acoustic respiration rate (RRa) may help clinicians assess respiratory status and help determine treatment options

9. Acoustic Respiration Rate (RRa): How It Works
Masimo Rainbow Acoustic Monitoring noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient’s neck.
Using patented acoustic signal processing that leverages Masimo’s revolutionary Signal Extraction Technology (SET), the respiratory signal is separated and processed to display continuous respiration rate.

10. FDA Accuracy Study: Methods
Healthy adult subjects were instructed to breath at rates ranging from 4 to 30 breaths per minute (brpm)
Waveforms were collected from both capnography and Rainbow Acoustic devices
Control reference was created
First obtained by a trained observer marking each breath based on listening to paired respiratory inspirations and expirations
Then verified visually with capnography waveforms and by listening to inspirations and expirations again (as done during auscultation)
Respiratory rates were determined for the control reference from the verified data
Bias, standard deviation, and root mean square accuracy (ARMS) were calculated for both capnography and Rainbow Acoustic devices compared to the control respiration rate

11. RRa FDA Accuracy Results: Similar to Capnography
FDA Submitted Accuracy, N=26 healthy volunteers

12. RRa Accuracy: Manual Method Comparison
Comparison of manual respiratory rate by stethoscope to Rainbow Acoustic Monitor RRa in 25 post surgical recovery patients

13. RRa vs. EtCO2 for Respiratory Pause Detection
Data retrospectively analyzed from PACU and General Floor monitoring episodes
Reference respiration rate determined by expert observer throughout each monitoring episode
Respiratory pause defined as 30 seconds with no breathing activity
86 monitoring episodes of respiratory pause identified
Sensitivity and specificity of Oridion Capnostream and Rainbow Acoustic Monitoring determined
Oridion
Capnostream
Masimo
Rainbow Acoustic Monitoring
v7706
Sensitivity
(respiratory pause detected when actual respiratory pause occurs)
39%
71%
Specificity
(no respiratory pause indicated when no actual respiratory pause exists)
98%
96%
Internal Masimo Data

14. Masimo Rainbow Pulse CO-Oximetry and Rainbow Acoustic Monitoring
Allow you to noninvasively and continuously monitor key indicators of:
Oxygenation (SpO2)
Ventilation (RRa™)
Circulation (PR)
Bleeding (SpHb™)
Helping you meet APSF guidelines for monitoring post-operative patients
Offering a breakthrough in patient safety for post-surgical patients on the general floor
Monitor More Patients, More Safely Than Ever Before

15. Rainbow Acoustic Monitoring Clinical Applications
General Care Floor with or without PSN
Any patient on Pain Management drugs (opioids)
All patients on PCA pumps
All OSA patients
All bariatric patients
Conscious Sedation Procedures (endoscopy, bronchoscopy)
PACU Patients
Patients currently continuously monitored with impedance pneumography where respiration rate is more important than ECG monitoring

16. Rainbow Acoustic Monitoring Devices

17. Clinical Samples

18. -- RRa - RAM -- RR - EtCo2-- SpO2

19. -- RRa - RAM -- RR - EtCo2-- SpO2

20. -- RRa - RAM -- RR - EtCo2-- SpO2

21. -- RRa - RAM -- RR - EtCo2-- SpO2

22. -- RRa - RAM -- RR - EtCo2-- SpO2

23. -- RRa - RAM -- RR - EtCo2-- SpO2

24. -- RRa - RAM -- RR - EtCo2-- SpO2

25. Patient with desaturations and multiple respiratory pauses
-- RRa - RAM -- RR - EtCo2-- SpO2
Patient with desaturations and multiple respiratory pauses