Rainbow Acoustic Monitoring

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

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

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) 33:667-679 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, 529-534 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): 882-4 (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

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

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.

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

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

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.

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

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

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

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

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

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

Rainbow Acoustic Monitoring Devices

Clinical Samples

-- RRa - RAM -- RR - EtCo2-- SpO2

-- RRa - RAM -- RR - EtCo2-- SpO2

-- RRa - RAM -- RR - EtCo2-- SpO2

-- RRa - RAM -- RR - EtCo2-- SpO2

-- RRa - RAM -- RR - EtCo2-- SpO2

-- RRa - RAM -- RR - EtCo2-- SpO2

-- RRa - RAM -- RR - EtCo2-- SpO2

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