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Evaluation of Nurse Alarm Notification Systems (NANS) for Postoperative Patients Receiving Opioids via Patient Controlled Analgesia American Society of Pain Management Nursing September 9, 2011 Mary Lynn Parker, M.S., R.N. Clinical Nurse Specialist, Orthopaedics/Trauma University of Michigan Health System University of Michigan Hospital Objectives Identify nurse assessment strategies to reduce the patient s risk of opioid-induced sedation and respiratory depression Describe the use of technological monitoring to reduce the patient s risk of over-sedation and respiratory depression 1

Safety and Monitoring Nurses continuously: Observe the patient and assess pain Patient rounding Critically analyze patient assessment data to determine patterns or change Make decisions about changing surveillance level frequency of post-op patients, or after giving opioid Intervene when patient in danger Document according to changes in patient condition Safety Recommendations Joint Commission National Patient Safety Goal Improve effectiveness of clinical alarm systems a) Implement regular preventive maintenance and testing b) Activated with appropriate settings and sufficiently audible with respect to distances and competing noise within the unit Institute for Safe Medical Practices and Anesthesia Patient Safety Foundation Need improved monitoring with patient controlled analgesia Safety Concerns Nuisance and desensitization created from high false alarm rates Interfere with communication due to excess noise Contribute to inadequate caregiver response Low priority alarms have status of false alarms Distract people leading to probability of medical error Reduce safety of patients on general care units 2

Pulse Oximetry 10 extinction coefficient (RED) 660nm (INFRARED) 905-940nm HbO2 Hb 0.1 600 700 800 900 1000 Wavelength (nm) Oxygenated Hgb & reduced Hgb absorb different amounts of red (RD) & infrared (IR) light Ratio of red/infrared light absorbed by hemoglobin determines SpO 2 SpO2 is estimate of SaO2 Arterial Saturation Functional Saturation: Percent of oxygenated hemoglobin available to transport O 2 Measured by conventional pulse oximeters Fractional Saturation: Amount of oxygenated hemoglobin as fraction of all measured hemoglobin Measured by co-oximeters Calculated Saturation: O2 saturation based on relationship between PaO 2 and SaO 2 Measured by pulse oximeter or oximeter R IR Hypoxemia vs. Hypoxia Hypoxemia: Insufficient O 2 in blood Arterial O 2 content or arterial O 2 partial pressure (PaO 2 ) SaO 2 or SpO 2 : < 90% (adults); < 94% (pediatrics) Individual baseline differences for chronic respiratory/cardiac diseases (COPD & CHF) Hypoxia: Insufficient O 2 at cellular level Symptoms irritability, anxiety, confusion, stupor, coma Can cause serious neurological or cardiac problems and lead to death 3

Capnography Monitoring concentration or partial pressure of CO 2 in respiratory gases Three phases I. Basal state II. Exhaled breath --rapid in CO 2 III. End of expiration-- alveolar CO 2 Known as end-tidal CO 2 or ETCO 2 Normal ETCO 2 differs from PaCO 2 by 2-5mm What Pulse Oximetry Does And Does Not Do Measures adequacy of oxygenation NOT adequacy of ventilation Measures oxygenation of arterial blood NOT adequacy of CO 2 elimination Yields high readings in patients with respiratory depression receiving oxygen Detects hypoxemia - failure of oxygenation Does not detect hypercapnia - ventilatory failure Background Safety of post-op patients on general care areas may be jeopardized due to: complexity Aggressive pain management Inadequate monitoring practices UMHS had patients on PCA therapy experience O2 desaturation To improve safe pain management practices, UMHS implemented a monitoring policy for adults receiving opioids via IV-PCA 4

Increased Need For Patient Monitoring Pulse oximetry made available at each bedside Three levels of oximetry monitoring defined 1. Continuous 2. Interval Uninterrupted SpO 2 monitoring < 24 hours while patient in bed, chair, or unattended --Can have sensor off when ambulating with PT, to BR, etc. (**Allows alert patient to ambulate without pulse O 2 cable tether) 3. Spot check UMHS Nurse Alarm Notification System (NANS) Patient HR or SpO 2 exceeds limits Monitor 1 Page (patient room info) Monitor 2 Page (patient room info) 15 Seconds Continuous Alarm 2 Minutes 15 Seconds Continuous Alarm Call Light (Green) Call Light (White + Green) Call Light (White blinking + Green) MONITOR LIMITS SpO 2 < 90 HR <60 >140 Specific Aims Describe oxygen desaturation events, alarm notification, and nursing response time Examine clinical relevance and predictive validity of system through desaturation events, alarm notification and interventions Examine reliability of system to convey clinically relevant events by quantifying missed notification of desaturation events 5

Objective To evaluate the effectiveness of an institutionallydeveloped centralized Pulse Oximetry Monitoring (POM) alarm notification system in facilitating nursing response and intervention for oxygen desaturation events in a general care postoperative setting. Methods Prospective study of adults s/p orthopedic surgery Patient controlled analgesia (PCA) for first 24 hours Pulse oximetry monitoring (POM) per policy IRB exempt Recorded total opioid dose in PACU and duration of PCA use Nursing interventions recorded by bedside nurses on data collection sheets and medical records Methods O 2 saturation data (HR and SpO 2 ) continuously captured via Masimo Rad-8 oximeters in three second intervals True desaturation events prospectively identified from streamlined POM data (ACSII format) SpO 2 <89 for >15 seconds Detailed alarm-paging data obtained Alarm notifications (nurse pages) extracted from continuous capture paging data 6

Methods Notification (nurse) pages matched by exact time to POM data, and coded as: Clinically relevant alarm events True desaturation event SpO 2 <89 for > 15 seconds (verified by ASCII data) Irrelevant artifact Inappropriate threshold Failure to delay notification Sample AGE 54.2 + 17.6 [range 19-86] WEIGHT (KG) (BMI) 84.7 + 23.4 [29.1 + 7.7] FEMALE 54 (57%) ASA PHYSICAL STATUS: I-II III-IV CO-MORBIDITIES: Cardiovascular Obesity Sleep disordered breathing Chronic Pain (opioids pre-op) CPAP (prescribed) PROCEDURE: Hip Other extremity Knee Spine 58 (62%) 36 (38%) 55 (59%) 38 (40%) 33 (35%) 22 (23%) 12 (14%) 27 (29%) 23 (25%) 20 (21%) 18 (19%) DURATION OF PCA USE (HRS) 24.5 + 15/97 DURATION OF SPO 2 MONITORING (HRS) 18.2 + 8.2 Pulse Oximeter Alarm Tiered Notification System SpO2 or HR exceeds limits (SpO 2 <89 in this setting) INITIAL ALARM 8 SEC INTERNAL DELAY Audible bedside alarm (via oximeter) NURSE ALARM NOTIFICATION SYSTEM ACTIVATED Solid green light outside room FIRST NOTIFICATION SECOND (ESCALATED) NOTIFICATION 15 SEC CONTINUOUS DESATURATION ALARM PAGE SENT TO NURSE 2 MIN 15 SEC CONTINUOUS DESATURATION URGENT PAGE SENT TO BEDSIDE NURSE & CHARGE NURSE Flashing green light outside room + Console display/tone change at central nursing station Flashing green & flashing white light outside room + Console double rate tone change at central nursing station 7

Results 103 patients monitored for 1616 hours 710 pages generated Nearly all patients experienced at least one desaturation 345 desaturation events Range: 0-53 Duration: 23.6 seconds Nurse response time 52.1 sec (days) 63.8 sec (nights) TREND IN SPO 2 OVER TIME IN ONE SUBJECT Results 36% of desaturation events were clinically relevant Missed events (no page triggered) occurred in 26% of true desaturation events Significantly related to paging burden (p=0.04) SpO 2 values lower during missed events vs. those triggering page 65% patients with events received interventions Primarily supplemental oxygen Description of Paging Events (n=672) And Nursing Response 8

Distribution of Desaturation Events Over Time Discussion Significant number post-op orthopedic patients with PCA experience desaturation triggering paging alert UMHS POM system facilitated timely nursing response Found 1 in 3 alarm pages during POM clinically relevant Promoted early interventions in approx. 50% Some desaturation events not triggering page Suggests potential gap in reliability Especially during times of high paging volume Discussion Possible solutions to improve safe/effective monitoring: System modifications paging delay may number of false pages Variable alarm SpO 2 < 86 for 30 seconds in some patients Decentralization to ensure safe & effective monitoring Ongoing analysis to determine % of desaturation events missed by NANS system Relationship between events and patient risk factors 9

Getting Information To The Bedside Pain assessment is more than just a pain score Critical thinking look at entire picture First night postop most risk prone Know opiate effect on respiratory rate & sedation score Assess patients continuously to evaluate response to care Institutional policies and standards indicate minimal requirements for documentation Nursing Education Policies and guidelines PCA Pulse O 2 & Opioid Monitoring for acute care/telemetry units Annual Nursing Blitz Opioid Modules Sedation Assessment, Respiratory Assessment, Opioid Safety Nursing Grand Rounds Meetings nursing leadership, educators, multidisciplinary Nursing orientation Nursing school Educational Topics Risk Factors for Opioid-Induced Respiratory Depression Know Your Patient Know Your Meds Sedation Assessment Respiratory Assessment Opioid Safety Rescue measures and meds 10

Risk Factors for Opioid-Induced Respiratory Depression Opioid naive especially first 24 hours Age extremes >60 years of < 12 months Overweight/obese Pre-existing conditions Respiratory: Sleep apnea, asthma, COPD, prematurity Hepatic/renal impairment; altered metabolism/excretion Neuromuscular disorders affecting respiratory effort Chronic pain history with high opioid requirements Risk Factors for Opioid- Induced Respiratory Depression (cont.) Complicated acute pain management in PACU, including: Airway obstruction Desaturation Patients who have required aggressive opiate administration Patients receiving 30milligrams of morphine (or its equivalent) Uncontrolled pain followed by aggressive analgesic administration Concurrent use of sedative meds Analgesia precedes Sedation which precedes Respiratory Depression 11

Level of Consciousness (Sedation) Level of consciousness (sedation level) is main concern after giving opioids Can be awake, but not alert Patient answers some short questions, but drifts off with more complex questions Potential for respiratory compromise becomes greater when sedated If see changes in level of consciousness (awake drowsy difficult to arouse), can anticipate potential respiratory changes (changes in depth, then rate) The Slippery Slope of Sedation CONSCIOUSNESS AWAKE MINIMAL SEDATION MODERATE SEDATION DEEP SEDATION SEDATION SCORE (UM) 0 1 2 3 UNCONSCIOUSNESS UNAROUSABLE 4 Malviya, S., et al, Br J Anaesthesia, 2002 Malviya, et al, British Journal of Anaesthesia, 2002 Sedation Assessment Awaken and rate patients sedation score using University of Michigan Sedation Scale (UMSS) Follow current hospital guidelines to document sedation assessments If patient asleep, and observations indicate no changes from previous assessment, chart sleeping and describe respiratory rate/quality See next slide for steps and instruction of UMSS 12

University of Michigan Sedation Scale (UMSS) 0 = Awake/Alert 1 = Minimally sedated: tired/sleepy, appropriately responds to verbal conversation and/or sounds 2 = Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation 3 = Deeply sedated: deep sleep, arousable only with significant physical stimulation 4 = Unarousable Malviya, S., 2002 Respiratory Effect of Opioids Opioids decrease ventilation: Rate of respirations Tidal volume Desensitization response at CO 2 receptors Increased CO 2 levels don t increase RR Body relies on the O 2 driven respiratory regulatory system which is less sensitive Even smaller opiate doses can RR, minute volume, and tidal exchange Quality Respiratory Assessment Respiratory rate, depth, regularity Respiratory effort Ineffective gas exchange? Breath sounds Abnormal sounds? Snoring, stridor, wheeze Any obstruction of airway? Patient Position 13

Respiratory Depression rate & depth of respirations from baseline Note trends respiratory rate <10/minute depth (quality) i.e., shallow, irregular, snoring, wheeze, accessory muscles Arterial O 2 content (SaO 2 ) or arterial O 2 partial pressure (PaO 2 ) SaO 2 or SpO 2 90% Assessing The Sleeping Patient Know baseline for your patient Know conditions that patient risk for opioid sedation Do thorough respiratory assessment Is the ventilation adequate? Rate, depth, regularity Look at patient with enough light to see Poor color/cyanosis are late signs of oxygenation When is peak effect and duration of meds given? Awaken patient and asses for sedation level and any abnormal respirations or concerns Case Example Assign Sedation Score To Patient Patient is asleep and breathing, but having difficulty awakening him even with physical stimulation Very somnolent; responsive Check respiratory rate/quality, SpO 2 Administer O 2, and call for assistance Notify M.D.; give Naxolone as ordered if patient on opioid Requires close monitoring May need higher level of care, tests, change in meds 14

Considerations for Over Sedated Patients Evaluate underlying causes Eliminate nonessential CNS-acting drugs If analgesia is satisfactory, reduce dose (by 10-25%) Consider giving lower opioid dose more frequently to peak serum concentration May need to add or nonopioid for additional pain relief Tolerance to sedative effect of opioid occurs over time If excessive sedation persists, switch to another opioid Is Your Patient In Trouble? Should You Call For Help? Changes from baseline level of consciousness Pinpoint pupils respiratory rate or change in quality of respirations Be aware of the difference between oxygenation and ventilation Hypotension Changes in heart rate Rescue Measures Call Rapid Response Team (RRT)- paging operator 141 Stop opioid & sedatives Stimulate patient and call for help Administer oxygen Stay with the patient & maintain airway Administer reversal agent if needed Monitor patient: SpO 2, RR, sedation 15

Causes of Agitation Symptom of distress Respiratory: hypoventilation Cardiac: low cardiac output Metabolic imbalance Neurologic status: ICP, trauma Pain/discomfort Critical Thinking Is Key What is normal and what are risk factors? Understand treatment rationale; how it impacts care Essential to communicate pertinent information Communication root cause >70% of all Joint Commission sentinel events Documentation --essential to do it!! Look at the whole clinical picture If something doesn t seem/feel right, check it out! Questions? 16

References Burgess L. Alarm limit settings for early warning systems to identify at-risk patients. J Adv Nsg 2009 ; 1844-1852. Critical alarms and patient safety. ECRI's guide to developing effective alarm strategies and responding to JCAHO's alarm-safety goal. Health Devices 2002; 31: 397-417 Dunwoody C, Krenzischeck C, el al. Assessment, physiological monitoring, and consequences of inadequately treated acute pain. Amer Soc PerAnesth Nrses 2008; 21(1), S15-S27. Edworthy J, Hellier E. Alarms and human behaviour: implications for medical alarms. Br J Anaesth 2006; 97: 12-7 Edworthy J, Hellier E. Fewer but better auditory alarms will improve pt safety. Qual Saf Health Care 2005; 14: 212-5 Eichhorn J. Recognizing and preventing hypoxemic injury risk on the general care floor. J Healthcare Risk Mx 2003, 21(1), 17-22. Fu ES, Downs JB, et al. Supplemental oxygen impairs detection of hypoventilation by pulse oximetry. Chest 2004; 126: 1552-8 Gabbay U, Bukchin M. Does daily nurse staffing match ward workload variability? Three hospitals' experiences. Int J Health Care Qual Assur 2009; 22: 625-41 References Hagel M, et al. Respiratory depression in adult patients with intravenous patient controlled analgesia. Orthopaedic Nursing 2004; 23(1), 18-27. Imhoff M, Kuhls S, et al. Smart alarms from medical devices in the OR and ICU. Best Pract Res Clin Anaesthesiol 2009; 23: 39-50 Imhoff M, Kuhls S. Alarm algorithms in critical care monitoring. Anesth Analg 2006; 102: 1525 Korniewicz DM, Clark T, David Y. A national online survey on the effectiveness of clinical alarms. Am J Crit Care 2008; 17: 36-41 Joint Commission. Disease Specific Care: National Patient Safety Goals. In: Joint Commission, editor. Chicago; 2005. Maddox R, Williams C, et al. Clinical experience with patient-controlled analgesia using continous respiratory monitoring and a smart infusion system. Amer J Hth-Sys Pharm;2006; 63(2), 157-64. Malviya S, Voepel-Lewis T, et al. Depth of sedation in children undergoing computed tomography: Validity and reliability of the Univ of MI Sedation Scale (UMSS). Br J Anes 2002; 88(2), 241-245. Marley R. Postoperative oxygen therapy. Amer Soc Peri Anes Nrs, Continuing Educ Articles Online 2006, 1-21 Minnick AF, Mion LC. Nurse labor data: the collection and interpretation of nurse-to-patient ratios. J Nurs Adm 2009; 39: 377-81 References Ochroch EA, et al. The impact of continuous pulse oximetry monitoring on intensive care unit admissions from a postsurgical care floor. Anesth Analg 2006; 102: 868-75 Overdyk FJ, et al. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg 2007; 105: 412-8 Pasero C, McCaffery M. Pain Assessment and Pharmacologic Management. Mosby; 2011. Phillips J. Clinical alarms: complexity and common sense. Crit Care Nurs Clin North Am 2006; 18: 145-56 Principles & guidelines for respiratory monitoring on the general care floor. The Consortium on Respiratory Monitoring on the General Care Floor. J Clin Monit 1996; 12: 411-6 Smith L. Opioid safety: Is your patient at risk for respiratory depression? Clin J Onc 2007; 11(2), 293-296. Sobieraj J, et al. Audibility of patient clinical alarms to hospital nursing personnel. Mil Med 2006; 171: 306-10 Taenzer AH, Pyke JB, et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology 2010; 112: 282- Taylor, S, et al. Postoperative day one: A high risk period for respiratory events. Amer J Surg 2005; 190, 752-756. Valdez-Lowe C, et al. Pulse oximetry in adults. Amer J Nrsg 2009; 109(6), 52-59. 17