michael becker, phd, rn vp nursing/ chief nursing executive patient safety & evidenced-based...

Michael Becker, PhD, RNVP Nursing/ Chief Nursing Executive

Patient Safety & Evidenced-Based

Monitoring Technologies

ECRI - Top 10 Health Technology Hazards 2015

Issued November 2014

Fourth year in a row Alarm Hazards is #1 on list

Inadequate alarm configuration policies and practices

This year, the report draws particular attention to alarm configuration practices. ECRI Institute is aware of several deaths and other cases of severe patient harm that may have been prevented with more effective alarm policies and practices.

www.ecri.org/2015hazards.

© 2013 Masimo Corporation

> “Improve the safety of clinical alarm systems”> As of July 1, 2014, leaders establish alarm system safety as a

hospital priority> During 2014, identify the most important alarm signals to manage> As of January 1, 2016, establish policies and procedures for

managing alarms

National Patient Safety Goal 06.01.01


> Numerous alarms, many false or non-actionable alarms> “one alarm every 66 seconds in one NICU”1, “771 alarms per bed per day in one ICU”1

> “≈85 to 99 percent of alarm signals do not require clinical intervention”2

> Staff can be overwhelmed by the number of alarms> Change alarm settings or mute alarms> Become passive to alarms – ignoring or delaying reaction time> Experience cognitive or operational disruption affecting other work tasks

> Delayed or lack of response to alarm conditions> January 2009 and June 2012: 98 alarm-related events, 80 resulted in death2

> Alarm fatigue – the most common contributing factor

The Problem

1 - Sun L. Washington Post. July 7, 20132 – The Joint Commission Sentinel Event Issue #50, April 8, 2013


Pulse Oximeters: The Most Common Monitor in Hospitals

Conventional Pulse Oximetry> Unreliable when needed most

Motion and low perfusion

> Clinical impact False alarms - increased workload and alarm fatigue Delayed clinical response Limited ability to aid in diagnosis / prognosis Patient disturbance


Venous & arterial averaging

Problem for Conventional Pulse Oximeters

0 50% 66% 86% 97% 100%

SpO2%

Venous and arterial averaging

Venous Arterial

Time

Abso

rptio

n

Motion causes venous blood movement


0 50% 66% 97% 100%

SpO2%

Masimo Signal Extraction Technology (SET®)Measures Through Motion and Low Perfusion

R/IR(Conventional

Pulse Oximetry)

DST®

Adaptive Filter FST ® SST™

Adaptive Filter MST™

Post Processor

DST Masimo SET 97%

0 50% 66% 97% 100%SpO2%

Evaluation and AnalysisPost Processor

Conventional Pulse Oximetry 66%

0 50% 66% 97% 100%

SpO2%

R/IR

ConventionalPulse Oximetry

R IR

Physiologic Signal

Algorithmic Analysis

OutputData

Digitized, Filtered, & Normalized


Post Processor

R/IR



Post Processor

R/IR




3%

43%

83%

5%

28%

18%

Missed True Alarms False Alarms

Masimo SET (V5.0)

Nellcor N-600 (V1.1.20)

GE TruSat

Shah N et al. J Clinical Anaesthesia. 2012.

Three-Way Comparison for True and False Alarms

This study measured the occurrence rate of missed true events during 40 low blood oxygen episodes and false alarms during 120 fully oxygenated episodes, both during conditions of motion. Motion was both machine and volunteer generated w/ results combined. A non-moving hand was used for the control / reference Spo2 value.

Masimo SET® Performance

97% 95% Sensitivity Specificity


The Need for Continuous Patient MonitoringFailure to Recognize Failure to Rescue

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• Adverse clinical events are preceded by a period of physiologic instability of 6-8 hours1,2

• Correlation between time to intervention and survival rate of in-hospital cardiac arrest3-6

• Even without cardiac arrest there is a correlation between time to intervention and avoidable morbidity7

• Early recognition of clinical deterioration is critical to patient outcomes

6 to 8 hoursMinutes


Patient Risks in Med-Surg Patient Population

> Diagnosed & un-diagnosed risk factors and comorbidities: ~40% US medical-surgical patient population > 65 years of age1

~36% US population defined as obese (BMI > 30)2

Obstructive Sleep Apnea in the adult surgical population estimated as high as 22%, with 70% of those patients being undiagnosed3

Meta-analysis on OSA screening tools, the authors concluded that it is likely that most of the screening tests will miss a significant proportion of patients with OSA4

OSA screening questionnaires: sensitivity in the 70% - 80% range and specificity in the 50% - 60%5

Chronic Obstructive Pulmonary Disease in the adult surgical population estimated to be 10% (general surgery) to 40% (thoracic surgery)6

Nearly half of COPD patients are undiagnosed7

1 – Hall MJ et al. Summary of National Hospital Discharge Survey 2007. Division of Health Care Statistics2 – U.S. Department of Health and Human Services. Centers for Disease Control and Prevention3 - Finkel et al. Prevalence of undiagnosed obstructive sleep apnea among adult surgical patients in an academic medical center, Sleep Med 2009 107 753-7584 –Ramachandran K, Josephs L. A Meta-analysis of Clinical Screening Tests for Obstructive Sleep Apnea. Anesthesiology 2009; 110:928-395 - Abrishami A, Khajehdehi A, Chung F. A systematic review of screening questionnaires for obstructive sleep apnea. Can J Anaesth.2010 May;57(5):423-38.2010Feb96 – Licker et al. Perioperative medical management of patients with COPD. Int J Chron Obstruct Pulmon Dis. 2007 December; 2(4): 493–515. 7 - National Institutes of Health. National Heart, Lung, and Blood Institute. 2012


Medication Risks in Med-Surg Environment

> High-risk / High-alert medications IV anticoagulants, insulin, opioids Parenteral opioids: IV PCA Morphine, IM Duramorph

> Opioid Induced Respiratory Depression 0.5%1 to 1.1%2 of post-operative patients receiving opioid-containing pain

management regimens experience respiratory depression As high as 11 patients per 1,000 in-patient surgeries annually

1 – The Joint Commission Sentinel Event Alert #492 – Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth 2004;93:212-2


Patient Observation on Med-Surg Units

> Nursing time, a precious commodity: Based on a time and motion study of nursing time1, Nurses spend as

few as: 8 minutes per patient per shift assessing and reading vital signs 43 minutes per patient per shift in the patient room Total of 22 hours per day that the patient is without direct nursing observation

Medical-surgical unit design minimizes line of sight and acoustics: Long corridors with a central nurse station or pod workstations Bathroom on corridor side of room

1 – Hendrich et al. A 36-Hospital Time and Motion Study: How Do Medical-Surgical Nurses Spend Their Time? The Permanente Journal/ Summer 2008/ Volume 12 No. 3


Impact of Respiratory Depression

> Incidence of respiratory depression among post-operative patients averages 0.5% - 1.1%

> So, for every 5,000 surgical patients, 25 will experience respiratory depression

> Failure to recognize respiratory depression and institute timely intervention can lead to cardiopulmonary arrest, resulting in brain injury or death


> “Safe use of opioids in hospitals”> “Serial assessments of quality and

adequacy of respiration and depth of sedation”

> Urges hospitals to take steps Prevent complications and deaths from opioids

> Incidence of respiratory depression 0.5% of all post-surgical patients

> Reasons for adverse events Dosing errors, improper monitoring of patients

and interactions with other drugs 29% related to monitoring

> Monitor both oxygenation ventilation Monitoring should be continuous Not intermittent spot checks

Sentinel Event Alert, Issue 49, August 8, 2012


Keeping Patients Safe on the General Floor


Patient SafetyNetRemote Monitoring & Clinician Notification System

The use of the trademarks Patient SafetyNet and PSN is under license from University Healthcare Consortium


“All patients should have oxygenation monitored by continuous pulse oximetry”

>“Capnography or other modalities that measure the adequacy of ventilation and airflow is indicated when supplemental oxygen is needed…”

>“Monitoring continuous oxygenation and ventilation from a central location …is desirable…information needs to be reliably transmitted to the healthcare professional caring for the patient at the bedside.”

Recommendations forPost-Operative Patient Monitoring

Stoelting RK et al. APSF. 2011. (www.apsf.org)


Respiratory Rate


Study of Indicators of Respiratory Depression

“All of these episodes were detected because the patient either took six or fewer breaths per minute or had an episode of apnea lasting longer than 20 seconds… the other two indicators of respiratory depression in this study (an end-tidal CO2 level of greater than 60 mmHg and oxygen saturation of less than 88%) did not contribute to the outcomes measured, suggesting that they may be less sensitive indicators of changes in respiratory function.”

Hutchinson R. AJN 2008.


Acoustic Respiration Rate (RRa™): Accurate and Patient-Tolerant Respiration Rate


U Penn Study: Impedance, Capnography, and rainbow Acoustic Monitoring™ vs. Manual RR During Procedural Sedation

> Subjects were 98 adults undergoing upper GI endoscopy> 3 methods were compared to a research assistant performing a manual

count> Assessment of the accuracy of respiration rate measurements and the ability

to detect apnea (cessation of breathing > 30 sec)

Goudra BG et al. OJ Anes Vol 3. No 2. Mar 2013.

Impedance Pneumography

Capnography(Oridion Microstream

Smart Capnoline)

Masimo rainbow Acoustic Monitoring™

V7804

Bias ± Precision(breaths per minute) 0.4 ± 5.9 4.8 ± 15.1 0.0 ± 1.0

Sensitivity for detection of apnea 45% 73% 73%

Specificity for detection of apnea 93% 12% 93%


rainbow Acoustic Monitoring™ and EtCO2 vs. Reference RR for Respiratory Pause Detection

> Data retrospectively analyzed from PACU monitoring episodes in 33 subjects over 3712 minutes> Reference respiration rate determined by expert observer throughout each monitoring episode

with simultaneous ability to assess capnography waveform, acoustic waveform, and hear breath sounds

> Respiratory pause defined as 30 seconds with no breathing activity> 21 episodes of respiratory pause identified

Oridion Capnostream

SARA V4.5

Masimo rainbow® Acoustic Monitoring

V7804

Sensitivity(respiratory pause detected when actual respiratory pause occurs)

62% 81%

Lower tolerance limit (0.95, 0.95)(% of time that 95% of devices will display data) 84% 94%

Ramsay M et al. Anesthesia & Analgesia. 2013.


rainbow Acoustic Monitoring™ and EtCO2 vs. Reference RR in a Pediatric Post-Surgical Population

> Thirty-nine of 40 patients (97.5%) demonstrated good tolerance of the acoustic sensor, 25 of 40 patients (62.5%) demonstrated good tolerance of the nasal cannula

Patino M et al. Pediatric Anesthesia. 2013.

Patient Tolerance

62.5%

97.5%


Masimo SET® and Masimo Patient SafetyNet: Helping Clinicians Improve Outcomes on the General Floor

Taenzer A et al. Anesthesiology, 2010.

Dartmouth Hitchcock Medical Center10 month study, covering 36 bed orthopedic unit • 2,841 patients and 9,978 monitored days • Rescue activations 3.4 to 1.2 per 1,000 patient discharges• ICU transfers from 5.6 to 2.9 per 1,000 patient days

There were no changes in these variables on two similar post-surgical units at the same hospital that did not continuously monitor with Masimo SET® & Patient SafetyNet

The use of the trademarks Patient SafetyNet and PSN is under license from University Healthcare Consortium


5 Year Mortality Impact with Masimo SET®

and Masimo Patient SafetyNet

No patients have suffered irreversible severe brain damage or died as a result of

respiratory depression from opioids

Since instituted on the original Dartmouth study unit in December of 2007

Taenzer AH and Blike G. APSF. 2012.


Additional Outcomes with Masimo SET®

and Masimo Patient SafetyNet

> 21% decrease in average length of stay of a patient with transfer to the ICU Total 5.1 days decreased (1.8 days in the ICU, 3.3 days on floor) Original orthopedic unit

> Similar clinical outcome improvements in the two additional post-surgical units General and thoraco vascular

Only 4 alarms per patient per day

Taenzer AH and Blike G. APSF. 2012.


Blood Transfusion Risks and Costs> Blood transfusions are common

Up to 20% of surgical patients Up to 35% of ICU patients receive 1+ units1,2

> Blood transfusions morbidity & mortality3,4,5

Up to 40% increase in 30-day morbidity Sepsis, pneumonia, wound infections & TRALI

Up to 38% increase in 30-day mortality Up to 67% increase in 6-month mortality

> Blood transfusions cost $$$ One of the largest cost centers in a hospital

Annually estimated at $1.6 to $6 million per hospital $522 to $1,183 per unit6

ICU LOS 2+ day increase per transfusion7

1 DeFrances et alAdvance Data. 2008;5:1-20. 2 Von Ahsehn N et al. Crit Care Med. 1999; 12:2630-2639. 3 Taylor RW et al. Crit Care Med. 2006; 34(9):2302-8. 4 Bernard AC et al. Journal of the American College of Surgeons. 2009;208:931-937. 5 Surgenor SD et al. Anesthesia & Analgesia 2009;108:1741-1746. 6 Shander A et al. Transfusion. 2010;50(4):753-65 5 . 7 Hill SR et al. Cochrane Database of Systematic Reviews 2000, Issue 1.


Undetected Bleeding Challenges> Significant bleeding common in surgical & critical care

Up to 35% of patients1

64% of hospital executives estimate 2 – 10 serious injuries/deaths annually from late detection of bleeding

> Bleeding is a significant risk factor Late detection further increases the risk2

19% in-hospital postpartum maternal deaths from hemorrhage3

> Bleeding significantly increases cost of treatment2

> Low Hb identifies almost 90% of patients with bleeding4

Traditional lab measurements infrequent and delayed> Joint Commission sentinel event alert: OB patients

Call for protocols that improve ability to detect hemorrhage5

1 Hebert PC. Crit Care. 1999: 3(2):57-63. 2 Herwaldt LA. Infect Control Hosp Epidemiol. 2003; 24(1):44-50.3 Bateman BT et al. Anesth Analg May 2010 110:1368-1373. 4 Bruns B et al. J Trauma. 2007; 63(2):312-5. 5 The Joint Commission, "Sentinel Event Alert: Preventing Maternal Death" Issue 44, January 26, 2010

© 2013 Masimo

Acquisition Cost of Blood is Just the Tip of the Iceberg

> Product / acquisition cost (each RBC est. @ $200 to $300)

> Activity-based costs Clinician time Overhead Waste

> Morbidity-related Costs> Readmissions

Shander A et al. Transfusion. 2010;50(4):753-765.


SpHbTM - Noninvasive, Continuous, Immediate


Multi-Wavelength Technology

• Only 2 wavelengths of light (660nm & 940nm) used to measure oxygen saturation (SpO2)

• SpHb uses 7 or more additional unique wavelengths, in combination with additional advanced algorithms, to measure SpHb, SpCO, SpMet , in addition to SpO2, PR, PI

Abs

orpt

ion

Wavelength (nm)


SpHb Accuracy - ICU

> 471 hemoglobin measurements from 62 Surgical ICU patients> 3 Hb methods compared to reference Hb (lab hematology analyzer: Sysmex XT2000i)

SpHb, satellite CO-Oximeter (Siemens RapidPoint 405), point-of-care device (HemoCue 301)

Frasca D et al. Crit Care Med. 39(10); 2011; 2277-2282.

1.0 g/dL (Arms)

1.1 g/dL (Arms)

1.3 g/dL (Arms)


> Provides a Real time view of changes in total hemoglobin vs. intermittent methods:

Value of Continuous Hemoglobin Monitoring

Rising Stable →Falling


Trend Plots: Continuous Noninvasive Hemoglobin

Target hemoglobin

range

tHb outside target range

SpHbContinuousHemoglobin

Trend


Results Patient Research> Patient recruitment over a six-month period

(Feb 2010 – July 2010)

> 350 patients screened, 327 enrolled 157 Standard Care, 170 SpHb

> Procedures: Hip replacement (31%) Knee replacement (29%) Spinal surgery (14%)

> 327 subjects in matched retrospective cohort From six-month period prior to study commencement Cohorts received no intervention

Ehrenfeld JM et al. ASA. 2010. LB05.


Frequency of Patients Receiving RBC Transfusion (%)

Ehrenfeld JM et al. ASA. 2010. LB05.

4.6% 4.5%

0.6%

0%

1%

2%

3%

4%

5%

Retrospective Cohort Standard Care Group SpHb Group

Fre

qu

ency

of

In

tro

op

erat

ive

Blo

od

Tra

nsf

usi

on

s

* †

* p=0.03 vs. Standard Care Group; † p=0.02 vs. Matched Retrospective Cohort


> Objective Determine whether Continuous SpHb monitoring helps to reduce surgical transfusion frequency and

average amount transfused in high blood loss surgery> Patients

Neurosurgery at academic medical center (Cairo University, Egypt)> Methods

Standard Care Group Treat as normally would

SpHb Group Treat as normally would but add continuous SpHb

Both Groups Blood samples taken at baseline and when EBL was ≥15% of total blood volume RBC transfusion initiated if hemoglobin was ≤10 g/dL and continued until the EBL was replaced and hemoglobin

>10g/dL

Prospective Cohort Study in High Blood Loss SurgeryObjective, Patients, Randomization & Methods

Awada W et al. STA. 2013 (abstract).


SpHb Monitoring Impact on Frequency of >3 RBC Unit Transfusions in High Blood Loss Surgery

↓56%Relative Reduction

*

Prospective cohort study in 106 neurosurgery surgery pts, 61 Standard Care & 45 SpHb*p<0.01 vs. Standard Care Group



SpHb Monitoring Impact on Average RBC Units Transfused per Patient in High Blood Loss Surgery

↓47%Relative Reduction

Prospective cohort study in 106 neurosurgery surgery pts, 61 Standard Care & 45 SpHb**p<0.001 vs. Standard Care Group

**



“ The first requirement in a hospital is that it should do the sick

no harm.”Florence Nightingale – Notes on Nursing

michael becker, phd, rn vp nursing/ chief nursing executive patient safety & evidenced-based...

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