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Our August 17, 2010
Patient Safety Tip of the Week Preoperative Consultation Time to Change suggested the 3 most important
things to screen for during a preoperative evaluation are frailty, delirium
risk, and obstructive sleep apnea. Frailty clearly has been linked to
post-operative adverse events and poorer patient outcomes following surgery
(see our multiple columns listed below).
We are always looking for simple tests for frailty that can
be applied in brief sessions in a surgeons office or other preoperative
assessment setting. In our May 16, 2017 Patient Safety Tip of the Week Are
Surgeons Finally Ready to Screen for Frailty? we noted a study that
looked at individual components of the Fried frailty phenotype measures (gait
speed, hand-grip strength as measured by a dynamometer, and self-reported
exhaustion, low physical activity, and unintended weight loss) in a primary
care setting (Lee
2017). The researchers found that individual criteria all showed
sensitivity and specificity of more than 80%, with the exception
of weight loss. The positive predictive value of the single-item
criteria in predicting the Fried frailty phenotype ranged from 12.5% to 52.5%. When
gait speed and hand-grip strength were combined as a dual measure, the positive
predictive value increased to 87.5%. They conclude that, while use of gait
speed or grip strength alone was found to be sensitive and specific as a proxy
for the Fried frailty phenotype, use of both measures together was found to be
accurate, precise, specific, and more sensitive than other possible
combinations and that assessing both measures is
feasible within the primary care setting.
Almost all the scales we use for detecting frailty include
measures of gait (such as the Timed Up-and-Go test or measures of gait speed).
But what about those patients in whom it is not possible to assess gait?
Some of our prior
columns on preoperative assessment and frailty:
References:
https://www.cfp.ca/content/63/1/e51
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2773096
Print January 2021 The Frailty Meter
One of the most common risks of MRI scanning is the risk of
thermal injury. Burns can result when any object containing metallic or
ferromagnetic material superheats during the scan. While most burns have
occurred due to things like superficial EKG electrodes or coils, the risk of
thermal injury has also been attributed to some unusual items: transdermal skin
patches, tattoos, tags on breast implants, ingested toy magnets, and even metallic
eyelashes (see our previous columns for April
2, 2019 Unexpected Events During MRI and September 2019 New MRI Hazard: Magnetic
Eyelashes).
Now the FDA has
issued a warning after receiving a report of a patient suffering facial burns
from a face mask during MRI FDA
2020.
That patient was wearing a face mask with metal during a 3-Tesla MRI scan of
the neck. The report described the burns to the patients face being consistent
with the shape of the face mask.
Some face masks and
respirators contain metal parts or coatings. The FDA notes that metal parts,
like nose pieces nose clips or wires, headband staples, nanoparticles (ultrafine
particles), or antimicrobial coating that may contain metal (such as silver or
copper), may become hot and burn the patient during an MRI.
The FDA acknowledges
that it may be appropriate for a patient to wear a face mask during an MRI
exam, especially during the COVID-19 pandemic. But it is critical to ensure the
face mask contains no metal.
FDA recommends that,
if the absence of metal cannot be confirmed and it is determined to be
appropriate for the patient to wear a face mask, an alternative face mask where
the absence of metal can be confirmed should be used. Health care providers who
perform MRI exams are encouraged to provide face masks without metal to
patients who will undergo an MRI.
Your pre-MRI
checklist, of course, includes screening for metallic objects. Looking at the
face mask could identify obvious metallic parts, like nose pieces or staples,
but wont reveal things like nanoparticles or coatings
mentioned in the FDA warning. The FDA warning does not mention whether metal
detection devices can detect some of those less obvious items.
That recommendation is echoed by Tobias Gilk, an
MRI safety expert whom we have cited in many of our columns (Yee
2020). "The staples holding the elastic to
the mask are too small to conduct heat, and since the COVID-19 pandemic,
patients have been imaged in masks that have nose bridges without injury,"
he said. "But antimicrobial treated fabric can heat up. So, to be safe,
patients should be provided with disposable surgical masks before their
MRI."
And, of course, appropriate
infection control procedures need to be followed when handling either the
patients own face mask or the one provided by the facility.
Lastly, it also
makes sense that your own MRI staff must wear face masks known to be free of
those metallic components. That would include other hospital staff who might
have to respond to an emergency in the MRI suite.
Metallic elements
are showing up more and more in places wed never
think of looking for.
Some of our prior
columns on patient safety issues related to MRI:
References:
https://www.auntminnie.com/index.aspx?sec=sup&sub=mri&pag=dis&ItemID=131064
Print January 2021 New MRI Risk: Face Masks
It was January a year ago that we wrote about an FDA warning
on gabapentinoids (see our January 2020 What's New in the Patient Safety World column FDA Warning on Gabapentinoids). In the past several years we had done a several columns on
dangers of gabpentinoids, alone or in combination
with opioids (see our What's New in the Patient Safety World columns for November 2017 Bad Combination: Gabapentin
and Opioids and March 2019 Gabapentin and Pregabalin on
the Radar Screen). So, it
came as no surprise to us that the FDA has issued a warning about gabapeninoids (FDA 2019).
But most of the warnings about
respiratory depression with gabapentinoids,
often when used in combination with opioids, were the result of anecdotal
reports and small case series. Then, in our February 25, 2020 Patient Safety Tip of the Week More
on Perioperative Gabapentinoids, we
discussed 2 studies by Duke University researchers from larger databases
looking at the impact of gabapentinoids used in the
perioperative period. Ohnuma et al. (Ohnuma 2019) analyzed data from a large administrative
claims database, including 862,524 patients from 592 hospitals, who underwent
elective primary THA or TKA between 2009 and 2014. They looked at the following
drugs, alone or in combination, on the day of surgery for patients undergoing
TKA or THA: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), gabapentinoids (gabapentin or pregabalin), or none of the
three drugs.
Compared to none of the three drugs as the reference
category, exposure to gabapentinoids was associated
with increased odds of naloxone use after surgery (OR 2.11), noninvasive
ventilation (OR, 1.45), invasive mechanical ventilation (OR 1.25), and ICU
admission (OR 1.28). A similar increase was seen in analgesic combinations
including gabapentinoids. The group receiving NSAIDs
plus acetaminophen showed the most protective associations with naloxone use
after surgery (OR 0.59), invasive mechanical ventilation (OR, 0.72), and ICU admission
(OR 0.69), and was associated with the lowest opioid consumption on the day
before discharge.
The authors conclude that preoperative gabapentinoids
were associated with significant increased risk of postoperative opioid-related
respiratory depression. It also failed to find benefits for gabapentinoids
in terms of postoperative opioid consumption and LOS. They recommended reconsideration
of routine use of preoperative gabapentinoids in the
adult TKA and THA population.
The researchers also looked at 108,616 patients who
underwent elective colorectal surgery across the 605 hospitals, 2% of whom received
gabapentinoids on the day of surgery (Yan 2019). They
found that use of gabapentinoids was associated with
higher odds of noninvasive ventilation (OR 1.39) and receipt of naloxone after
surgery (OR 1.70). There was no difference in invasive mechanical ventilation,
opioid consumption, or LOS. They cite other small studies showing increased
risk of postoperative respiratory depression and naloxone use in patients
receiving gabapentinoids, which may be explained by
an interaction between gabapentinoids and opioids.
Now, a new study (Bykov
2020) analyzed data from the large Premier Research
database to assess use of perioperative gabapentinoids
in relation to the risk of opioid-related adverse events in surgical patients.
The study population included adults admitted for major surgery between October
2007 and December 2017 who were treated with opioids on the day of surgery.
Overall, gabapentinoids with opioids were
administered to 892,484 of 5 547 667 eligible admissions (16.1%). Overall,
441 overdose events were identified, with absolute risks of 1.4 per 10,000
patients with gabapentinoid exposure and 0.7 per 10,000
patients receiving opioids only. Following propensity score trimming, the
adjusted hazard ratio for an overdose in those receiving gabapentinoids
and opioids compared to those receiving opioids only was 1.95. But the absolute
risk was small. To put it in perspective, the number needed to treat (NNT) for
an additional overdose to occur was 16,914 patients. Adjusted hazard ratios for
secondary outcomes were 1.68 for respiratory complications, 1.77 for
unspecified adverse effects of opioids, and 1.70 for the composite outcome of
the 3 outcomes. The results were consistent across sensitivity analyses and
subgroups identified by key clinical factors.
In our attempts to reduce the use of perioperative opioids, the use of
multimodal analgesia has been front and center. One component of many
multimodal analgesia regimens has been gabapentinoids. The
Bykov study is somewhat reassuring in that the
absolute risk of untoward complications is small. The overall occurrence of adverse outcomes was very low,
with overdoses occurring in less than 0.1% of patients. Yet, it does confirm
that concomitant use of gabapentinoids almost doubles
the risk of overdose and increased the risk of respiratory complications by
about 70%. That certainly calls for careful consideration of when gabapentinoids should be used perioperatively and when they
might be best avoided.
Others have questioned the risks and benefits of perioperative
gabapentinoids. In our February 25, 2020 Patient Safety Tip of the Week More on Perioperative Gabapentinoids we discussed a systematic review and meta-analysis on
perioperative use of gabapentinoids (Verret 2019) that
found no clinically significant analgesic effect for the perioperative use of gabapentinoids, with low level of evidence, and an
increased risk of adverse events with moderate level of evidence. The authors
concluded that their results do not support the use of gabapentinoids
for the management postoperative acute pain in adult patients.
Unfortunately, the studies from the large databases do not
tell us what other risk factors may have contributed to the adverse events
related to patients receiving gabapentinoids. Taking
those risk factors into account might allow better selection of patients who
might benefit from gabapentinoids without the risks
of respiratory depression. For example, we might avoid using gabapentinoids in patients at risk for obstructive sleep apnea
(OSA).
So, again, mixed messages from the Bykov
study the absolute risk from gabapentinioids is low
but they do increase the risk of adverse events in those patients receiving opioids
perioperatively.
Hospitals and ambulatory surgical centers should include a
look at gabapentinoids in their analysis of events
following surgery. Particularly in view of the Obnuma
study mentioned above (Ohnuma 2019),
they should also look to see if the intended rationale for use of gabapentinoids (to reduce the need for opioids) actually achieved that goal.
Some of our prior columns on safety issues with gabapentinoids:
References:
FDA (US Food and Drug Administration). FDA warns about
serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin,
Gralise, Horizant) and
pregabalin (Lyrica, Lyrica CR)When used with CNS
depressants or in patients with lung problems12-19-2019
https://www.fda.gov/media/133681/download
OhnumaT, Raghunathan K, Ellis A, et
al. Abstract S-344 Effects of Acetaminophen, NSAIDs, Gabapentinoids
and Their Combinations on the Day of Surgery in Total Hip and Knee
Arthroplasties. Anesthesia & Analgesia 2019; 128(5): 741
https://iars.app.box.com/v/AM19AbstractSupplement
Yan R, Ohnuma T, Krishnamoorthy V,
et al. Abstract S-353 Gabapentinoids on the Day of
Colorectal Surgery Are Associated with Adverse Postoperative Respiratory
Outcomes. Anesthesia & Analgesia 2019; 128(5): 760
https://iars.app.box.com/v/AM19AbstractSupplement
Bykov K, Bateman BT, Franklin JM,
Vine SM, Patorno E. Association of Gabapentinoids With the Risk of Opioid-Related Adverse
Events in Surgical Patients in the United States. JAMA Netw
Open 2020; 3(12): e2031647
Verret M, Lauzier F, Zarychanski R, et al. Perioperative Use of Gabapentinoids for the Management of Postoperative Acute
Pain: A Systematic Review and Meta-analysis. 2019 annual meeting of the
American Society of Anesthesiologists (ASA; abstract A2096).
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=18&absnum=1927
Print January 2021 Gabapentinoids
Again
Weve done several columns on the impact of surgical case duration on
post-op complications and surgical outcomes (see the full list below). Weve often cited a study (Procter 2010) that looked
at a large database of general surgical procedures and demonstrated a linear
relationship between duration of surgery and infectious complications. This
relationship persisted even after adjustment for a variety of other risk
factors for perioperative infections. The unadjusted infectious complication
rate increased by 2.5% per half hour. Hospital length of stay (LOS) also
increased geometrically by 6% per half hour. Logically, prolonged operative
time would also be expected to increase pressure-related complications, such as
decubiti and perioperative neuropathies. Longer duration also increases the
likelihood of increased foot traffic into and out of the OR and the potential
for distractions and interruptions, potentially contributing to errors.
A new study (Chen
2020) used data from the American College of Surgeons National Surgical
Quality Improvement Program database on almost 15,000 patients who had
undergone revision total knee arthroplasties (TKAs) between 2007 and 2016.
After adjustment, each additional 15 minutes of operative time increased the
likelihood of wound complications (odds ratio 1.023), postoperative blood
transfusion (odds ratio 1.169), and extended hospital stay (odds ratio 1.060).
Of course, from such database statistics one cannot determine the reason for
the prolonged surgical durations. In some cases, whatever led to complications
may have also prolonged the surgery. But, undoubtedly, in many cases the complications
resulted from the long surgical durations.
We recommend hospitals and any
facility performing surgical procedures have a system in place to remind all
the OR staff of surgical duration. After a set amount of time (based upon the
average or expected duration for each type of surgery), someone such as the
anesthesiologist should verbally call out the case duration so all staff are aware. Such announcement should be repeated
every 10-15 minutes. That may alert staff to the need to reposition the
patient, administer a second course of prophylactic antibiotics, etc.
Our prior columns
focusing on surgical case duration:
References:
Procter LD, Davenport DL, Bernard AC, Zwischenberger
JB. General Surgical Operative Duration Is Associated With
Increased Risk-Adjusted Infectious Complication Rates and Length of Hospital
Stay, Journal of the Amercican College of Surgeons
2010; 210: 60-65
https://www.journalacs.org/article/S1072-7515%2809%2901411-2/abstract
Chen AZ, Gu, A, Wei C, et al. Increase in Operative Time Is
Associated With Postoperative Complications in
Revision Total Knee Arthroplasty. Orthopedics 2020;
Orthopedics. 2021;44(1):xxxx
Posted November 25, 2020
Print January 2021 Operative Time and
Postoperative TKA Complications
Print January
2021 What's New in the Patient Safety World (full column)
Print January 2021 The Frailty Meter
Print January 2021 New MRI Risk: Face Masks
Print January 2021 Gabapentinoids
Again
Print January 2021 Operative Time and
Postoperative TKA Complications
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