Capnography, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

8 Key Points to Improving Patient Safety: Physician-Patient Alliance for Health & Safety Presents at AORN Annual Conference 2014

At the annual conference of Association of periOperative Registered Nurses (AORN), which took place March 30 – April 2, 2014, the Physician-Patient Alliance for Health & Safety (PPAHS) presented eight key points to improve patient safety and health outcomes.

Three of the most commonly overlooked clinical points are:

  • Verify hand–off or transition of care from nurse-to–nurse that continuous electronic monitoring is in place, has been maintained and double-checked.
  • Double check PCA dosing, pump parameters, and continuous monitor settings.
  • Include in the post-operative orders daily lead changes and hands off communication on lead changes to decrease nuisance alarms.

Lynn Razzano RN, MSN, ONCC (Clinical Nurse Consultant for PPAHS), who represented PPAHS at the AORN conference, says that the tremendous interest shown by AORN nurses in the PPAHS presentation shows how important is the proper management and monitoring of patients receiving opioids. Ms. Razzano recounts what conference attendees told her about the vital need to order continuous electronic monitoring:

“Perioperative nurses emphasized to me that they should be the identified patient advocate for safety and ensure all patients receiving opioids are ordered continuous electronic monitoring. Although perioperative pace is hectic and there is tremendous pressure to conduct quick operating room turnover, perioperative nurses can never forget that their commit to the patient does not end following surgery. Following surgery, the post-operative order for continuous electronic monitoring should be made for all patients receiving opioids.”

The eight key clinical relevant points were contained in poster presentation #29 entitled, “First National Survey of Patient –Controlled Analgesia Practices: Results and Implications for Standards, Nursing Assessment and Patient Safety”. Please click here to view a PDF of the handout of the PPAHS poster.

Capnography, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

Monitoring the High-Acuity Patient: Does Risk Stratification Increase or Decrease Patient Safety?

by Dr. Frank Overdyk (Executive Director for Research, North American Partners in Anesthesiology, and Professor of Anesthesiology at Hofstra University School of Medicine)

Summary: The topic of who is a suitable candidate for outpatient surgery is front and center with productivity pressures being intense at ambulatory surgery centers. However, with surgery often comes the necessity of the use of opioids for pain control. Studies have shown that any patient receiving opioids may be at risk of postoperative respiratory depression and if undetected, respiratory arrest  (also known as “Code Blue”). The most common antecedents to cardiopulmonary arrest are of respiratory origin. Respiratory decompensation—as evidenced by tachypnea, bradypnea, hypoxia, hypercarbia or changes in mental status—are often the earliest warning signs of physiologic instability. Monitoring respiratory function and level of consciousness are especially important in detecting and preventing adverse events for patients receiving opioids and sedatives.

The topic of who is a candidate for outpatient surgery looms large at this time with throughput pressures being intense at ambulatory surgery centers. According to the report Ambulatory Surgery in the United States, 2006, the number of outpatient surgeries in the United States increased from 20.8 million in 1996 to 34.7 million in 2006. While outpatient surgeries only accounted for about half of all surgeries in 1996, by 2006 they made up nearly two-thirds of all surgeries in 2006.

There is often a sentiment that “it’s only minor surgery”. While a surgery may indeed be “minor” or less intensive and complicated, and non opioid analgesics are preferred in these cases, opioids are still frequently required for adequate postoperative pain control. The Anesthesia Patient Safety Foundation convened a symposium in 2006 on the dangers of postoperative opioids, and the consensus opinion was that opioid-induced respiratory depression (OIRD) remains a significant and preventable threat to patient safety for which institutions must have zero tolerance. Moreover, in 2011, APSF reiterated that clinically significant drug-induced respiratory depression (oxygenation and/or ventilation) in the postoperative period remains a serious patient safety risk that continues to be associated with significant morbidity and mortality.

Unrecognized postoperative respiratory failure that results in cardiopulmonary arrest (CPA) is a daily occurrence at healthcare facilities across the United States. Since CPA results in death or anoxic brain injury in the majority of cases, these events have been termed “Failure to Rescue (FTR)”. FTR is the first and third most common patient safety-related adverse events affecting the Medicare population in U.S. hospitals, accounting for 113 events per 1,000 at-risk patient admissions. Moreover, fifty percent of Code Blue events involve patients receiving opioid analgesia.[1]

In their review of the approaches to address fail failure-to-rescue (FTR), Dr. Andreas Taenzer and his colleagues found that previous attempts have largely focused, with limited success, on improving the response to an identified patient crisis.Such approaches have led to the development of rapid response teams (RRTs). However, the primary determinant for the success of RRTs has been found to be early recognition.[2]and this is where continuous electronic monitoring may provide a early-detection solution.

Postoperative patients usually receive opioid analgesia by patient-controlled analgesia (PCA). PCA has become part of accepted medical practice and is generally considered more effective and safer than conventional IM (Intramuscular) injection of opioids.

However, conventional PCA monitoring by nurses at the bedside fail to detect frequent episodes of slow breathing (bradypnea) and desaturation that continuous electronic monitoring have revealed.[1]  The current standard of care for postoperative monitoring typically require vital signs and less commonly a SpO2 value, initially at 30-min intervals, but thereafter at intervals as far as 2–4 h apart. As recent APSF recommendations and conclusions state:

Intermittent ‘spot checks’ of oxygenation (pulse oximetry) and ventilation (nursing assessment) are not adequate for reliably recognizing clinically significant evolving drug-induced respiratory depression in the postoperative period.

Patient surveillance systems that use continuous monitoring with oximetry and capnography would facilitate early recognition of patient deterioration, as illustrated in the chart below:

This early detection of patient deterioration through patient surveillance must be distinguished from condition monitoring. In condition monitoring, patients are risk stratified to identify those with certain conditions, such as sleep apnea, obesity, low body weight, or age, and more caregiver resources are devoted to these patients.

In contrast, patient surveillance monitoring is used for all patients. In the operating room, for example, all patients receiving sedation are monitored in the same manner — all according to standards set by the American Society of Anesthesiologists. This includes oxygen saturation, blood pressure, electrocardiogram, and ventilation.

This approach applied outside of the operating room on all postoperative patients receiving opioids and sedatives, whether by PCA or IM, would provide early detection of patient deterioration and thereby would allow RRTs to intervene at the earliest detectable moment.

However, to apply continuous electronic monitoring to a large number of patients raises two critical issues.

First, nuisance alarms and alarm fatigue become an issue. One type of false alarms are those in which the monitor threshold value for a variable is reached but not physiologically accurate, examples of which are a malpositioned or missing transducer, or a patient who is moving.

In the Taenzer study, technical false alarms by removing “null” data elements and data from witnessed, misplaced transducers from the database. We acknowledge some technical artifact resulting in false positive alarms may remain. Trend analysis and multivariate interpretation of related data, such as RR and ETco2, are other techniques used to identify technical false alarms.

Second, investment in existing technology raises the concern that better technology is being developed. However, as Dr. Robert Stoelting (President, Anesthesia Patient Safety Foundation) explains, “Future technology developments may improve the ability to more effectively utilize continuous electronic monitoring of oxygenation and ventilation in the postoperative period. However, maintaining the status quo while awaiting newer technology is not acceptable” [Dr. Stoelting’s emphasis].

Further research needs to conducted to clarify patient characteristics and under which conditions this occurs and will improve alarm algorithms to reduce the high false positive alarm rate typical of threshold triggered alarms. Until this research is done, increased monitoring of oxygenation with oximetry and the adequacy of ventilation of patients receiving opioids and sedation is warranted.


[1] Overdyk FJ, et. al., “Continuous Oximetry/Capnometry Monitoring Reveals Frequent Desaturation and Bradypnea During Patient-Controlled” Analgesia Anesth Analg 2007;105:412–8

[2] Fecho K, Jackson F, Smith F, Overdyk F: In-hospital resuscitation: Opioids and other factors influencing survival. Ther Clin Risk Manag 2009; 5:961–8

[3] Calzavacca P, Licari E, Tee A, Egi M, Haase M, Haase-Fielitz A, Bellomo R: A prospective study of factors influencing the outcome of patients after a Medical Emergency Team review. Intensive Care Med 2008; 34:2112– 6

Patient Safety, Patient-Controlled Analgesics, PCA

Monitoring Technology for PCA Pumps Can Prevent Adverse Events with Patient-Controlled Analgesia (PCA): So Why Are Hospitals Not Using It?

By Michael Wong

(This article has also been published in SurgiStrategies, which can be read here.)

According to its newly-updated, “How-to Guide: Prevent Harm from High-Alert Medication”, the Institute for Healthcare Improvement (IHI) looked at high-alert medications, which are “more likely than other medications to be associated with harm”.

One of the areas that the IHI singles out is narcotics. The IHI guide points out the necessity and importance of narcotics in treatment:

Pain management is an important component of patient care. Implementing appropriate pain management protocols not only ensures that patients receive pain relief, but also minimizes opportunities for errors and harm. Effective pain control is integral to good health and to recovery from injury, surgery, and illness.

However, with this benefit may come the potential for harm. As the guide finds:

A review of costs associated with errors related to patient-controlled analgesia (PCA) and device related narcotic errors found that each error cost $552 – $733; harmful errors were 120 – 250 times more costly than those without harm. The authors estimated an annual rate of 407 PCA related and 17 device-related errors per 10,000 people in the United States.

However, adverse events with PCA pumps may occur even without an error being committed by attending healthcare professionals. As Frank Federico, RPh (Executive Director at IHI) points out, “Many patients may experience harm even with appropriate dosing of narcotics. This is a critical point for patients, their families and their caregivers to know — a patient may experience respiratory depression, leading to death, even if the PCA pump has been programmed correctly. Many believe that some of the adverse effects are the cost of doing business.  Our goal should be to reduce all harm, understanding that we may not know how to today. When a patient dies from respiratory depression, the toll on the patient’s family, friends, and community are enormous. The cost of adverse events goes beyond the costs associated with a medical malpractice claim.”

In their study, “Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability,” researchers determined that mortality from programming errors with PCA pumps was estimated to be a low-likelihood event (ranging from 1 in 33,000 to 1 in 338,800), but relatively high in absolute terms (ranging from 65 to 667 deaths). In other words, when harm from PCA occurs, it is likely to result in death.

Moreover, when PCA pump events were correlated against costs, quite understandably, non-harmful events were estimated to cost about $28 per event, but a harmful adverse event determined to be opioid related was $13,803 per event, as this study, “The Rate and Costs Attributable to Intravenous Patient-Controlled Analgesia Errors” showed:

As Rodney Hicks , PhD, APRN, FAANP, FAAN (Professor, Western University College of Graduate Nursing, Pomona, California), says, “Our study highlighted that IV PCA has a higher likelihood of errors, because of the complexity of IV PCA administration. Practitioners should capitalize on capnography and future innovations, such as linking monitoring alarms to the hospital’s network, to alert staff when a patient may be experiencing respiratory depression. Using such technology will realize potential cost savings or avert future costs associated with adverse events with PCA pump.”

Steps taken by Veterans Health Administration to avert PCA events echo these sentiments. As Bryanne Patail, biomedical engineer at the U.S. Department of Veterans Affairs, National Center for Patient Safety describes how VHA implemented a “strong fix” to reduce PCA-related events by more than 60%:

Use of PCA pumps is a process, and improving that process is an area that involves many stakeholders. In looking at fixes, they can be categorized as strong, intermediate or weak fixes. The strongest fix for PCA pumps is a forcing function, such as an integrated end tidal CO2 monitor that will pause the pump if a possible over infusion occurred. So, healthcare providers should first look at these strong fixes. There they will see the most impact on reducing errors and improving patient safety.

Moreover, I asked David Watson (VP at ECRI Institute) whether ECRI concurs with VHA’s recommendations. ECRI is an independent, nonprofit organization that researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care.

Watson replied to me:

Infusion devices regularly appear within our Top 10 Technology Hazards list.  We cited PCA pumps within that list back in November 2010 in relation to the risks of oversedation and the associated potential for narcotic induced respiratory depression.  Infusion systems should be viewed as one component of a medication delivery system.  Other components within the process may include the need to ensure adequate monitoring is in situ.  In relation to this ECRI Institute is aware of previous studies suggesting that the concurrent use of pulse oximetry and capnography can lead to the early identification of respiratory depression. 

We have previously recommended the development of an action plan to implement effective physiological monitoring of patients on PCA therapy.  As such, I would concur with the VHA recommendations on this.

In short, we currently have the technology to catch and prevent many adverse events with PCA pumps. As Dr. Robert Stoelting (President, Anesthesia Patient Safety Foundation) explains:

Future technology developments may improve the ability to more effectively utilize continuous electronic monitoring of oxygenation and ventilation in the postoperative period.  However, maintaining the status quo while awaiting newer technology is not acceptable” [Dr. Stoelting’s emphasis].

Capnography, Monitoring Liability and Costs, Patient Safety, Patient-Controlled Analgesics, PCA

How often do errors with patient-controlled analgesia (PCA) occur?

by Michael Wong

Many readers of this website have asked, how often do errors with patient-controlled analgesia (PCA) occur?

In a retrospective analysis lead by Rodney Hicks (who at the time of the study was Manager, Patient Safety Research and Practice, United States Pharmacopeia), the magnitude, frequency, and nature of non-harmful and harmful medication errors associated with PCA were studied. (Professor Hicks is now Professor, Western University College of Graduate Nursing, Pomona, California).

Over the five-year review period, of the 919,241 medication errors records from the 801 reporting healthcare facilities, just 1% (or 9,571) were associated with PCA. Although 1% may seem insignificant, this analysis was based on the voluntary medication error reporting program, MedMarx.

“Although generalization of voluntary reported findings to the general population should be done cautiously,” as Professor Hicks points out, “The general rule of thumb is that for every reported event, there can be between 300-1,000 unreported events.”

Using this rule of thumb, based on 9,571 reported events, this would mean that between 2.8 million and 9.6 million total events (unreported & reported) occurred over the five-year period from July 1, 2000 to June 30, 2005. On an annualized basis, this would mean that about 600,000 to 2 million events per year could involve PCA.

“A further study would need to be done to ascertain the total number of PCA events,” explains Professor Hicks, “but the problem is extensive in my opinion.”

Moreover, when the study looked at the number of events that caused harm, there were 624 records of PCA associated with harm, corresponding to 6.5% of the patients. Again, while 6.5% may seem small, as the study found, “By comparison, during the same period, only 1.5% of all other errors reported to MedMarx led to harm. This represents a fourfold higher relative risk of harm for PCA events.”

“All health care disciplines were implicated in the errors, including physicians, pharmacists, and nurses” Hicks reported.  “Therefore, it will take an inter-disciplinary team to resolve the problems”.

As Professor Hicks concludes:

Our analysis was in no means trying to discourage the use of PCA pumps. Many studies have shown the benefits of using PCA, including improved pain management, better utilization of nursing resources, increased patient satisfaction, and improved pulmonary function.

However, this is clearly an area that standardization needs to occur and organizations need to invest in training and policies and procedures as well as equipment – all areas to promote safety.

Moreover, although elimination of error is critical, studies have shown even a correctly programmed PCA pump poses patient safety risks. In their study, “Continuous Oximetry/Capnometry Monitoring Reveals Frequent Desaturation and Bradypnea During Patient-Controlled Analgesia”, Dr. Frank Overdyke and his colleagues point out, “The most serious complication of patient-controlled analgesia (PCA) is respiratory depression (RD).” They found that:

continuous respiratory monitoring is optimal for the safe administration of PCA, because any RD event can progress to respiratory arrest if undetected.

As Ray Maddox and his colleagues point out in their study “Intravenous Infusion Safety Initiative: Collaboration, Evidence-Based Best Practices, and ‘Smart’ Technology Help Avert High-Risk Adverse Drug Events and Improve Patient Outcomes”:

Even correctly programmed, appropriate doses of opiates can suppress respiration and decrease heart rate and blood pressure. Episodes of bradypnea and desaturation can escalate to respiratory depression (RD) requiring rescue. The success rate for in-hospital cardiopulmonary resuscitation remains less than one in five patients. If detected early, most cases of opioid-induced respiratory depression can be treated with naloxone. However, severe cases can be fatal.The risk of patient harm due to medication errors with PCA pumps is 3.5-times the risk from any other type of medication administration error.

These researchers therefore recommend:

Capnographic monitoring—measurements of ventilation using respiration and exhaled carbon dioxide (EtCO2)—is particularly important because it can provide an earlier warning of respiratory depression than pulse oximetry (SpO2) in some patient populations.

What do you think? Are you aware of any other studies that have looked at PCA error incidence rates?

Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

Preventing “Dead In Bed Syndrome” with Patients After Surgery

by Michael Wong

In our recently conducted survey among healthcare providers, almost all the respondents (85%) favor the development and use of safety checklists.

Because of this strong desire of healthcare professionals to have a checklist, PPAHS is putting together a working group to create a checklist targeted towards patient-controlled analgesia. This checklist would reinforce the need for continuous electronic monitoring for oxygenation and ventilation. For studies and Anesthesia Patient Safety Foundation recommendations on patient-controlled analgesia, please click here.

“We should stop the found dead in bed syndrome,” says Dr. Andrew Kofke (Co-Director at Hospital of the University of Pennsylvania Neurocritical Care Program). “The use of a well-constructed checklist that ensures proper procedures are followed in patient-controlled analgesia would enhance patient safety.”

An example of a checklist is the surgical checklist that was created and is being promoted by the World Health Organization and through the efforts of Dr. Atul Gawande (Associate Professor of Surgery at Harvard Medical School and General and Endocrine Surgeon at Brigham and Women’s Hospital).

“Avoidable failures are common and persistent, not to mention demoralizing and frustrating,” Dr. Gawande says. “And the reason is increasingly evident: the volume and complexity of what we know has exceeded our individual ability to deliver its benefits correct, safely, or reliably.”

“A checklist would help ensure that necessary procedures are followed when a patient is provided with a PCA pump,” explains Dr. Elliot Krane (Director, Pediatric Pain Management at Lucile Packard Children’s Hospital at Stanford).

“When there is a handoff of a patient from team to team, or location to location (such as OR to PACU, OR to ICU, ICU to OR, etc.), I have been impressed that there are times in which things fall through the cracks, from relatively minor things like missed doses of antibiotics, to critical things like ventilators not being properly connected, potentially resulting in hypoxia,” says Dr. Krane.

Do you think that a succinct checklist (5 or 6 key items) targeted at patient-controlled analgesia would enhance patient safety?

If you may be interested in assisting to develop such a checklist, please email PPAHS at mike.ppahs@gmail.com

Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

Post-Surgical Patients Require Better Monitoring

by Michael Wong

PPAHS encourages the adoption of the Anesthesia Patient Safety Foundation (APSF) recently released recommendations to improve the safety of patients by continuously monitoring patients following surgery.

According to the HealthGrades study of patient safety in American hospitals, “failure to rescue” and postoperative respiratory failure (also known as “Code Blue”) are the first and third most common patient safety related adverse events affecting Medicare patients accounting for 113 events per 1,000 at-risk patient admissions.

“These adverse events which affect both Medicare and non-Medicare patients result in death or anoxic brain injury in the majority of cases,” observes Dr. Daniel Sessler, who is Professor and Chair of the Department of Outcomes Research at the Cleveland Clinic, and Director of the Outcomes Research Consortium which is anesthesia’s largest academic research organization. The Consortium conducts research in anesthesia, critical care, and comprehensive pain management.

“Continuous respiratory monitoring, including the use of both capnography and pulse oximetry, is essential for the safe administration of patient-controlled analgesics,” explains Professor Sessler. “A patient experiencing respiratory depression, if undetected, can easily progress to respiratory arrest and consequent brain damage or death.”

A capnograph is a monitoring device that measures the concentration of carbon dioxide” that a person breathes out in exhaled air and displays on a numerical readout and waveform tracing; and a pulse oximeter is a device for measuring the amount of oxygen in blood.

To improve patient safety and health outcomes, the Anesthesia Patient Safety Foundation recently released recommendations calling for continuous electronic monitoring of oxygenation and ventilation.

As Dr Robert Stoelting (President, Anesthesia Patient Safety Foundation) explains, “Clinically significant drug-induced respiratory depression (oxygenation and/or ventilation) in the postoperative period remains a serious patient safety risk that continues to be associated with significant morbidity and mortality.”

How monitoring is currently conducted on postoperative patients may not be enough. As the APSF recommendations state, “Intermittent ‘spot checks’ of oxygenation (pulse oximetry) and ventilation (nursing assessment) are not adequate for reliably recognizing clinically significant evolving drug-induced respiratory depression in the postoperative period.” In other words, better monitoring for patient safety is needed and APSF recommends that use of current technology to improve patient safety.

Just ask Carly Ann Pritchard who suffered an ankle injury and then underwent surgery to reduce lingering pain from her ankle injury. Unfortunately, although she survived surgery, she suffered brain damage because of an accidental overdose from a morphine-filled pain pump — after surgery. A California appeals court recently upheld a jury’s award of about $9.9 million in damages.

Moreover, as the APSF guidelines provide, using capnography and oximetry monitoring on all postoperative patients is recommended, and not just for patients who may have an obvious increased risk of postoperative respiratory insufficiency (such as those with obstructive sleep apnea, obesity, or chronic opioid therapy).

Observes Dr. Frank Overdyk (Professor of Anesthesiology and Perioperative Medicine at the Medical University of South Carolina), “Serious postoperative adverse events such as deaths and anoxic brain injuries due to opioid acute pain management are a significant and preventable threat to patients, for which all institutions and healthcare providers must have zero tolerance”.

However, waiting for future technology to manage this issue is not acceptable. As Dr Stoelting explains, “Future technology developments may improve the ability to more effectively utilize continuous electronic monitoring of oxygenation and ventilation in the postoperative period.  However, maintaining the status quo while awaiting newer technology is not acceptable” [Dr Stoelting’s emphasis].

Monitoring Liability and Costs, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

What are the costs of implementing patient safety?

by Michael Wong

St. Joseph’s/Candler Health System (SJCHS) found out that the “costs” over a 5-year period of implementing a patient safety initiative was the prevention of at least 471 adverse events, a return on investment of $1.87 million, an internal rate of return of 81%.

Here’s the problem that SJCHS was trying to solve — Patient controlled analgesia (PCA) pumps give patients the power to control when pain medication (as prescribed by their doctor) is delivered to them by computerized pumps connected directly to the patients’ intravenous line (IV). Typically, PCA pumps are used by patients recovering from surgery, but of course any patient coping with pain may be provided a PCA pump.

Monitoring with pulse oximetry and capnography could enhance patient safety

Unfortunately, as the researchers relate in their study, “Intravenous Infusion Safety Technology: Return on Investment”, the use of PCA is “associated with significant hazards” to patients. Data gathered by MEDMARX and United States Pharmacoppeia from 1998 to 2005 indicate that patient harm increases more than 3.5 times when PCA is used. Moreover, according to the FDA, in 2004, the use of PCA was associated with 106 adverse events (including 22 deaths) and large-volume pumps were associated with 390 adverse events (including 17 deaths).

Consequently, SJCHS replaced its existing traditional IV pumps with “smart” IV safety systems. These smart IV safety systems contain drug libraries, best practices, and alerts that are designed to help prevent IV medication errors.  In addition, these smart systems included pulse oximetry (which monitors the oxygenation of the patient’s hemoglobin) and capnography (which measures the concentration of carbon dioxide exhaled by the patient). Shown below, averted error rates: risk of harm per 1,000 patient-days:

As the researchers concluded, “Implementation of these smart systems reduced high-risk medication errors and PCA-related undesired outcomes and provided an impressive 5-year ROI of $1,866,973 and an IRR of 81%”:

The question is no longer, “Can we afford to implement IV safety systems?” The real question is, “Can we afford not to?”

What do you think? (For more statistics and another study on how monitoring technology can improve patient health and safety, please see Postoperative Patient-Controlled Analgesics.)