Respiratory Depression Surveillance September 26, 2017

Learning Outcome(s)

• Recognize that respiratory compromise is a critical inpatient complication that dramatically increases the likelihood of adverse outcomes and drives the cost of patient care

• Review the clinical problem and regulatory guidelines that support increased interventions for enhancing patient surveillance and patient safety while receiving opioids post-operatively

• Evaluate the current monitoring strategies for the early identification of postoperative respiratory compromise to improve patient outcomes and reduce the cost of care

• Discuss a the spectrum of monitoring including continuous patient monitoring strategies

Case Study

• 58y/o RN admitted for surgical repair of disc at C6

• Post-op with PCA and regional cervical block

• Arrived to Med-Surg floor 430pm, family at bedside, with PCA

• 7pm all family go home, patient is more somnolent and no c/o pain

• 9pm patient found unresponsive by CNA

Let’s Discuss this Case

• Pre-op assessments often miss the risk for apnea or obstructive sleep apnea

• Bedside monitor for Pulse Ox /End Tidal CO2

• No continuous vital sign monitoring • Continuous would have demonstrated an acute changes

Why Talk About Respiratory Compromise

• 2nd leading avoidable patient safety issue in the US

• 3rd most rapidly increasing hospital inpatients cost in US

• 13.7/1000 patients experience respiratory event s/p surgery

• 5th top condition leading to increased hospital costs

• $7.8 billion spent on respiratory compromise in hospitals

Why Focus on Respiratory Compromise

• Changes in respiratory vital signs corresponding with respiratory compromise often precede in-hospital deterioration and often missed and are associated with increased mortality

• Many in-hospital declines may have been prevented with better monitoring and early intervention to address evolving respiratory compromise

Respiratory Compromise Pyramid

Failure

Insufficiency

Arrest

Early detection is KEY

Respiratory Compromise

• Respiratory compromise is a state in which there is a high likelihood of decompensation leading to:

• respiratory insufficiency • respiratory failure • respiratory arrest or death

• Early detection is KEY- from insufficiency to failure

Definition of Respiratory Compromise

Hypoventilation occurs when ventilation is inadequate to perform needed gas exchange By definition it causes an increase concentration of CO2-

• Decreased Respiratory Rate (RR)

• Decreased Pox

• Increased CO2

Categories of Respiratory Compromise

• Post-Operative Respiratory Failure (PRF) • Post-Operative Medical-Surgical patients

• Routine • Complex co-morbidities • Orthopedic procedures are most for ~41% of all inpatient

procedures

• Opioid Induced Respiratory Failure (OIRF)

• S/P Trauma

Medical–Surgical Nursing in 2017

• Single patient rooms, long corridors

• No central monitors

• Patient ratios

• Electronic Charting (nursing time not spent in direct care)

• BMA

• Alarm Fatigue Syndrome

What Can Be Done

Real-Time Connectivity, with Continuous Monitoring and Clinical Surveillance Solutions Improve Patient Safety Across the Continuum of Care

ED OR/PACU ICU STEPDOWN

MED-SURG

OUTPATIENT HOME

Anesthesia

Respiratory Compromise Pyramid

Failure

Insufficiency

Arrest

Early detection is KEY

Post-Operative Respiratory Failure

What is post-operative respiratory failure? (PRF)

• Postoperative respiratory failure “respiratory failure” is a broad descriptor and can include pneumonia, aspiration, adult respiratory distress syndrome (ARDS), and pulmonary emboli

• Serious pulmonary complications such as respiratory failure can delay, or even prevent, complete recovery

Pathophysiology of Post-Operative Respiratory Failure (PRF)

• Respiratory failure is caused by either impaired alveolar gas exchange or inadequate ventilation • Hypoxemic and hypercapnic • Patients commonly have a combination of both

• Following surgery, serious pulmonary complications such as respiratory failure can delay, or even prevent, complete recovery

• In order for clinicians to apply necessary preventive and/or interventional treatments, careful monitoring in the post-surgical setting is absolutely critical

Opioid Induced Respiratory Failure (OIRF)

• Effective pain management is a priority of care and a patient right (Joint Commission, 2010)

• >56,000 adverse events & 700 patient deaths linked to patient-controlled analgesia

• Advances in pain science justify the need for more aggressive pain therapies to reduce pain severity and the likelihood for both short- and long-term consequences of unrelieved pain

• Patients arrive for surgery for a diverse background and medication usage and history

Opioid-Related Deaths In-Hospitals Joint Commission Sentinel Event Alert: (Issue 49, August 8, 2012)

• Most serious adverse effect: respiratory depression, generally preceded by sedation

Sentinel Event Database Between 2004 & 2011 • 47% wrong does medication errors • 29% improper monitoring of the patient • 11% other factors, including excessive dosing, medication interactions, adverse drug

reactions

Evaluation of closed claims over 20 years 75 million cases, all anesthesiologists nationwide (D.I. Sessler, “Preventing Respiratory Depression”. Anesthesiology, V122, No 3, 484-5. March 2015)

• Half resulted in settlements $217,000 (median) • Most patients whose claims resulted from respiratory events were given opioids • Only 25% were at risk of OSA no relationship to STOP-BANG scores

Identifying Apnea & Respiratory Depression • 20,000 annual incidents of RD-related interventions (naloxone rescue)

attributed to opioid delivery (AAMI) • Immense variability exists in how sedation-related AEs are reported,

tracked -- imprecise, inconsistent, and capnography can be key to early identification (Mason et al.)

• Respiratory depression: capnography provides immediate information about CO2 production, ventilation/perfusion (V/Q) status (Spiegel)

• Obstructive sleep apnea is a risk factor for postoperative hypoxemia as upwards of 20% of elective surgical patients have OSA, most of whom lack a formal diagnosis (Khanna, 2016)

• Continuous monitoring is perhaps the obvious way to prevent catastrophic postoperative respiratory events (Sessler 2015)

Sources: AAMI; Wong et al. 2013; Spiegel 2013; Mason et al. 2012

Patient Identification the Real Challenge

• STOP-BANG does not predict hypoxemia in adults recovering from noncardiac surgery

• Surgical patients present with increasingly complex medical conditions, co-morbidities, making perioperative care more challenging (D. Supe et al. “Continuous Surveillance of Sleep Apnea Patients in a Medical-Surgical Unit.” BI&T May/June 2017)

• Obstructive sleep apnea (OSA), characterized by recurrent periods of airflow cessation (hypopnea) associated with oxygen desaturation (hypoxemia) up to 20% of elective surgical patients, most lacking formal diagnosis (A.K. Khanna et al. “Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis”. BJA, 116(5): 632-40 (2016

Who is at Risk

• Aged 61-70; 2.8x higher, 71-80; 5.4x higher, 80+ 8.7x higher

• Opioid use (naive or tolerant) • Age ,Weight • Co-morbidities, Hx of smoking

• Underwent coronary artery bypass grafting (CABG), thoracic surgery, or procedures on the head and neck

• Reacted adversely to a particular anesthetic agent

• Experienced a high-level spinal cord injury or severe head trauma

Why is Early Identification of RPF Important?

• Outcomes improve with earlier identification • Decrease mortality • Decrease LOS • Increased cost to patient and facility

Why use it as a quality indicator? (AHRQ) Agency for Healthcare for Research and Quality (Patient Safety Initiative) PSI-11

“Patients don’t suddenly deteriorate.

Healthcare professionals suddenly notice.”

Symptom Recognition is KEY

• Confusion • Disorientation • Lethargy/ fatigue • Headache • Dizziness / nausea

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Early

Late • Shallow, slow breathing

with little noticeable chest movement

• Apnea, cyanosis

{ {

Treatment of Respiratory Compromise

• Oxygen therapy

• Reversal agents

• Fluid therapy

• Continuous positive airway pressure, CPAP, or BIPAP

• Mechanical ventilation

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Failure

Insufficiency

Arrest

Cost of Respiratory Compromise

All 3 Phases- insufficiency, failure and or arrest

• Mortality – increases 39.4%

• LOS – 7- 15 days or longer

• Average Cost increases at least $20 to $27k

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Sources of Data Surrounding the Physician & Clinical Staff Members

Vitals

Infusions

Orders & Non-Infusion Medication Administration

Treatment, Observations

& Documentation

Notes, Dictation & Research

Who to Monitor

Selective monitoring vs. universal monitoring

Risk stratification- can lead to misses of patients with undiagnosed sleep apnea (25-30%)

2

Monitoring of Patient Vital Signs Measurements of body’s most basic functions: (M. Elliott, A. Coventry, “Critical care: the eight vital signs of patient monitoring.” British Journal of Nursing, 2012, Vol 21, No 10 pp 621-5)

• Body temperature • Pulse • Respirations • Blood Pressure • Temperature • Arterial oxygen saturation (POX) • Pain • Urine Output

Essential in assisting identification of clinical deterioration (L. Rose & S.P. Clarke, “Vital Signs”. AJN. May 2010. Vol 110, No 5. Page 11.)

According to the McCarter study-at Main Line Health here in PA

• Most respiratory depression events occurred within the first 24 hrs. of initiating PCA therapy

• With a mean time of 3.4 hrs., excluding an outlier with 23.5 hrs.

• The average time was 5.6 hrs.

• In addition, 1 patient had an event 23.5 hrs. after starting PCA

When to Monitor

Types of Monitoring

Episodic (spot check) (Curry & Jungquist “A critical assessment of monitoring practices, patient deterioration, and alarm fatigue on inpatient wards: a review. Patient Safety in Surgery 2014 8:29)

• Every 2-4 hours • Action arouses patient • Patients left unmonitored 96% of the time

Source: J. Venella, “We See You When You’re Sleeping: Addressing Patient Safety Risks Surrounding Opioid-Induced Respiratory Depression.” Bernoulli Webinar. Nov. 30th, 2016

Continuous • Remote monitoring • Tele-operator “analytics • Relay to floor nursing • Dependent on clinical communication tools

Spot Check Vital Signs

• Intermittent observation and recording of patient’s pulse, breathing rate, and O2 saturation

• Every 2-4 hours • This action typically

arouses the patient • Patients are left unmonitored

96% of the time

www.ncbi.nlm.nih.gov/pmc/articles/PMC4109792

Discrete Data Signal Sampling Can Miss Triggering Events

J.R. Zaleski / ANIA 2017 32

Time (sec) 0 10 20 30 40 50 60

V0 V30 V60

V0

V30

V60

Discrete Values, V(t)

Telemetry

• Remote surveillance • Human analytics • Relay system • Often delayed • Dependent on clinical

communications tools

Respiratory Depression Safety Surveillance • ~20,000 in-hospital respiratory depression

rescues per year in US; average cost of critical incidents over $500K

• Existing monitoring insufficient - excessive false alarms, lack of communication

• IRB study of real-time analytics (multi-variable alarms) showed 99% less alarms with no missed actual patient events

• ROI: avoid rescues/ICU transfers, decreased mortality, reduced LOS and increased bed capacity

Source: AAMI Foundation 2015 Opioid Safety & Patient Monitoring Compendium

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Proven Clinical Results

Continuous Monitoring

• Detects subtle changes in respirations and trends and provide actionable information prior to deterioration

• Current methods of detecting and preventing opioid-induced respiratory depression have limitations, but continuous monitoring using available technologies could still prevent a significant number of cases of patient harm

• Reduce burden the nurses workload, with more technology, but to provide an enhanced level of observation with actionable notifications with data capture through this technology

Continuous Monitoring

• Detects & provides comparison of state changes & trends in patient condition

• YET…capturing data alone does not provide an adequate mechanism for detecting respiratory depression

• Augment data collection with more intelligent ways of combining data to reveal more actionable information

Continuous Monitoring with Smart Alarms

• The most sophisticated category is the use of smart alarms that are transmitted to a device held by direct-care clinical staff.

• The use of smart alarm technology serves two primary purposes:

• Smart alarms provide an accurate and real-time picture of a patient’s condition, enabling direct-care patient staff and physicians to intervene before a patient begins to deteriorate.

• Attenuating alarm data achieves the balance between communicating contextual patient-safety specific information and minimizing spurious and non-emergent events that are not indicative of a threat to patient safety.7

Describing Smart Alarms

Sustained alarms: • Which sets a minimal time threshold that the alarm must be violated prior to sending

alarm

Consecutive alarms: • Which patterns of a consistent alarm detected, occurring over a clinician-defined period of

time

Combination alarms: • Which multiple parameters from different devices occurring simultaneously may together

indicate a degraded patient condition

Trending alarms: • Which expand or contract patient alarm limits on individual devices

Ideal State

• Capturing data and monitoring alone is not enough

• Surveillance with integration into the electronic medical record

• Embedded analytics would provide a best practice platform for the patient and would assure a highest level of quality and safety

3

Alarm Fatigue

• 100’s of alarms/day per patient

• 1000’s of alarms/day per unit

• 10,000’s of alarms/day per hospital

Alarm Fatigue

• Alarm Fatigue • Overwhelmed by information • Desensitized to number of alarms

• Improper Responses • Turn down volume • Turn off alarms • Adjust settings outside of safe limits

• Serious or Fatal Consequences • Patient falls • Delays in treatment

Achieving Continuous Monitoring

• Technology needs (middleware, physiologic devices, smart alarms)

• Workforce needs (training, mobile devices, team-approach to implementation)

• Business needs (the “hidden” cost of sentinel events)

Case Study • 84y/o female, post fall 5 fx ribs with pleural effusion • Travels and obtains norovirus • Admitted from ED with acute dehydration • Over the next 2 days continues with persistent water loss stools, vomiting

and nausea • IV hydration • Med-surgical floor, RN ratio-1:4/6 patients • Day 5 – (5pm) develops extreme SOB, chest pain, decrease O2 • Spot Check vs all night • Next am chest x-ray and d-dimer test and CT Scan at 2pm • Multiple PEs

Let’s Discuss the Case Study

• No continuous vital sign monitoring • Continuous would have demonstrated an acute change in resting HR and POx

• Baseline injury was trauma- no care of s/p trauma with baseline DVT precautions

• (Pneumatic compression stockings at the foot of the bed, applied only the 1st of 6 days), no compression socks

• Outcome- heparinization (3 additional hospital nights)

• 10 days acute rehab

Summary & Recommendations

• Continuous monitoring should be used with patients monitored post-operatively

• POX unreliable when supplemental O2 is used

• If O2 is administered, hypoventilation detection through capnography

• Enhance education on use of capnography, particularly in identification of normal ranges and out-of-norm observations

• Increased costs of monitoring need to be weighed against: • Reduced rapid response calls • Decreased transfers to ICU (& LOS) • Reduced staffing burdens • Fewer rescues with Naloxone HCL • Improved nursing satisfaction and reduced nuisance alarms • Increased patient safety & satisfaction

Thank You / Questions

References

• Cvach, 2012; Feder & Funk, 2013; Gorges, Markewitz, & Westenskow, 2009; Graham & Cvach, 2010; Sendelbach & Funk, 2013.

• (Medscape: B.S. Stetka, MD. “The Evolving Role of Opioids in Managing Chronic Pain”. May 1st, 2017)

• The Joint Commission, Patient Safety Advisory Group. (2013, April 8). Sentinel Event Alert. Medical device alarm safety in hospitals. 50. Retrieved from: http://www.jointcommission.org/sentinel_event.aspx

• Supe et al. “Continuous surveillance of sleep apnea patients in a medical surgical unit.” BI&T May/June 2017

• T.A. Morris et al. “Respiratory Compromise as a New Paradigm for the Care of Vulnerable Hospitalized Patients” Respiratory Care * April 2017 * Vol 62 * No 4 * Page 502