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By Michael Wong, JD (Founder/Government Director, Doctor-Affected person Alliance for Well being & Security)
Opioid-induced respiratory despair can result in severe opposed occasions and even demise, in hospitalized sufferers. In its Sentinel Occasion Alert #49, titled “Protected use of opioids in hospitals”, the Joint Fee said, “Whereas opioid use is usually secure for many sufferers, opioid analgesics could also be related to opposed results, probably the most severe impact being respiratory despair, which is usually preceded by sedation.” The alert was retired as of February 2019 and is now addressed within the fee’s ache administration requirements for hospitals.
About half of in-hospital cardiorespiratory occasions happen on the final care ground. Usually these occasions are deadly. Lars W. Andersen, MD (Division of Drugs, Regional Hospital Holstebro, Aarhus College & Division of Emergency Drugs, Beth Israel Deaconess Medical Heart) and his colleagues concluded that acute respiratory occasions are widespread in inpatient wards within the US and are related to a mortality price of just about 40%.
Consequently, figuring out the sufferers who’re susceptible to opioid-induced respiratory despair can be immensely useful in stopping these dreaded occasions. With this aim in thoughts, Ashish Ok. Khanna, MD, FCCP, FCCM, FASA (Affiliate Professor and Vice-Chair of Analysis; Director, Perioperative Outcomes and Informatics Collaborative; Division of Anesthesiology, Part on Important Care Drugs, Wake Forest College Faculty of Drugs, Atrium Well being Wake Forest Baptist) and his colleagues carried out the PRODIGY (PRediction of Opioid-induced Respiratory Melancholy In Sufferers Monitored by capnoGraphY) trial. I interviewed Dr. Khanna concerning the trial.
Inform me concerning the PRODIGY trial and why it’s so vital in enhancing affected person security?
The PRODIGY trial investigated the early detection of affected person deterioration utilizing steady, digital cardiorespiratory monitoring – pulse oximetry and capnography – with an enrollment goal of 1,650 sufferers at 16 facilities in North America, Europe, and Asia. A complete of 1,335 sufferers receiving parenteral opioids on the final care ground have been included within the evaluation. These sufferers have been constantly monitored with pulse oximetry, which measures a affected person’s oxygen saturation degree, and with capnography, which measures the quantity of (or end-tidal focus of) the carbon dioxide launched on the finish of the affected person’s expiration. From these measurements, my staff and our collaborators within the trial group have been capable of develop a threat prediction instrument for Opioid-Induced Respiratory Melancholy (OIRD).
What does the PRODIGY threat evaluation instrument inform us about which sufferers are most at-risk for opioid-induced respiratory despair?
The PRODIGY threat evaluation instrument makes use of 5 impartial variables: age over 60 years of age (in many years), intercourse, opioid naivety, sleep issues, and continual coronary heart failure. All of those variables are simply out there within the EMR or could be gathered from a radical historical past taking and scientific evaluation. Importantly, the instrument is straightforward to make use of, out there and could be configured on the bedside by all ranges of suppliers (not simply physicians ), and would even be very simply deployable as an actionable alert within the EMR.
Let’s speak about age and opioid-induced respiratory despair. I’m over 60 years of age. Am I extra in danger than a 50-year-old man of affected by opioid-induced respiratory despair? Or, put one other method, am I much less susceptible to affected by opioid-induced respiratory despair than an 80-year-old man?
The PRODIGY trial discovered that advancing age (measured in many years) is a predictor of opioid-induced respiratory despair. That is in keeping with different respiratory despair threat prediction fashions.
Sufferers who’re greater than 60 years previous are at a higher threat for opioid-induced respiratory despair. This threat will increase considerably in a affected person who’s in his 80s versus a affected person who’s in his 60s. For instance, with no different PRODIGY threat elements, solely having an age > 80 places a affected person at a PRODIGY rating of 16 which is the very best threat of OIRD and about 6 occasions as a lot as a affected person lower than 60, and twice as a lot as a affected person between 60-70 with an analogous profile. Age-related adjustments in respiratory physiology and altered opioid pharmacokinetics are more than likely contributing to this elevated threat.
We assigned level scores for every of the 5 traits ─ age, intercourse, opioid naivety, sleep-disordered respiration, and continual coronary heart failure:

In fact, the PRODIGY threat evaluation instrument is barely a information. It isn’t an absolute predictor. For instance, whereas a affected person’s age over 60 is an efficient predictor, there have been many situations the place youngsters have suffered and even died from opioid-induced respiratory despair.
So, does the PRODIGY threat evaluation instrument work in “actual” life? What has the expertise of a hospital utilizing the PRODIGY threat evaluation instrument?
In January 2019, two hospitals within the Lehigh Valley Well being Community began utilizing PRODIGY-guided bedside monitoring of all postoperative sufferers on the final care ground prescribed parenteral opioids. These sufferers have been monitored with steady pulse oximetry till no less than 9 a.m. on postoperative day 1. Steady capnography was added in these with sleep-disordered respiration, morbid weight problems, neuraxial opioid administration, supplemental oxygen administration, or on the anesthesiologist’s discretion.
The researchers have been led by Thomas M. McLoughlin Jr., MD, the chair of anesthesiology at Lehigh Valley Well being Community. I’m happy to report that they haven’t noticed a single opioid-induced respiratory depression-related mortality or code blue occasion in a monitored affected person since implementing the PRODIGY threat evaluation instrument. Different as but unpublished information and knowledge coming by from educational and non-academic medical facilities has been very encouraging and all traits level to the worth of enhancing steady monitoring for our sufferers with an rising emphasis on wi-fi wearables which can be much less obtrusive to normal submit operative rehabilitation.
What are the largest impediments to hospitals and healthcare services utilizing the PRODIGY threat evaluation instrument?
Capital prices, specifically the acquisition of pulse oximetry and capnography tools, are elements. In our evaluation of the cost-benefit of utilizing steady pulse oximetry and capnography monitoring of normal care ground sufferers, we discovered that steady pulse oximetry and capnography monitoring of high-risk sufferers is projected to cut back annual hospital prices by $535,531 and cumulative affected person size of keep by 103 days. A mere 1.5% discount in respiratory despair would obtain a break-even level and justify the funding. The likelihood of cost-saving is ≥ 80% if respiratory despair is decreased by ≥ 17%.
Enlargement of steady monitoring to high- and intermediate-risk sufferers, or to all sufferers, is projected to achieve a break-even level when respiratory despair is decreased by 2.5% and three.5%, respectively, with a ≥ 80% likelihood of price financial savings when respiratory despair decreases by ≥ 27% and ≥ 31%, respectively.
Moreover, studying new processes and altering previous habits should be thought-about. Enterprise consultants have recognized a lot of obstacles to the adoption of recent applied sciences, and healthcare professionals are definitely not proof against such challenges. These obstacles embrace resistance to alter. In different phrases, doing one thing new or totally different can certainly be tough.
In a current survey of 5744 anaesthesiologists I did with Frederic Michard, MD, PhD, and his colleagues, we discovered that “Steady monitoring of important indicators with wi-fi sensors is needed by most anaesthesiologists from college hospitals in Western Europe and within the USA. They consider it could enhance affected person security and end result, however can also be difficult to implement due to price and connectivity points.”
What can medical societies and affected person security advocates do to encourage the usage of the PRODIGY threat evaluation instrument?
Medical societies and affected person security advocates just like the Doctor-Affected person Alliance for Well being & Security ought to encourage adoption and facilitate a greater understanding of the usage of the PRODIGY threat evaluation instrument.
Get to know the way the PRODIGY threat evaluation instrument, turn into accustomed to it and learn the way to implement it ─ these are steps healthcare professionals ought to take to enhance affected person security. Dr. Frank Overdyk, who was a co-investigator for the PRODIGY trial, and I can be placing collectively a seamless medical training course on the affected person security implications and utilizing the PRODIGY threat evaluation instrument. I’d encourage my fellow docs, nurses, and respiratory therapists to take this course.