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Author Manuscript
Can J Anaesth. Author manuscript; available in PMC 2011 October 1.
Published in final edited form as:
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Can J Anaesth. 2010 October ; 57(10): 888–897. doi:10.1007/s12630-010-9366-5.

The incidence of hypoxemia during surgery: evidence from two


institutions

Jesse M. Ehrenfeld, MD, MPH,


Department of Anesthesia, Critical Care, & Pain Medicine, Massachusetts General Hospital, 55
Fruit St, Jackson 458, Boston, MA 02114, USA
Luke M. Funk, MD, MPH,
Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA; Department of Health
Policy and Management, Harvard School of Public Health, Boston, MA, USA
Johan Van Schalkwyk, MB,
Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand
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Alan F. Merry, MB,


Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand; Department of
Anaesthesiology, University of Auckland, Auckland, New Zealand
Warren S. Sandberg, MD, PhD, and
Department of Anesthesia, Critical Care, & Pain Medicine, Massachusetts General Hospital, 55
Fruit St, Jackson 458, Boston, MA 02114, USA
Atul Gawande, MD, MPH
Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA; Department of Health
Policy and Management, Harvard School of Public Health, Boston, MA, USA
Jesse M. Ehrenfeld: [email protected]

Abstract
Purpose—The incidence of hypoxemia in patients undergoing surgery is largely unknown and
may have a clinical impact. The objective of this study was to determine the incidence of
intraoperative hypoxemia in a large surgical population.
Methods—We performed a retrospective study of electronically recorded pulse oximetry data
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obtained from two large academic medical centres. All adults (age ≥ 16 yr) undergoing non-
cardiac surgery during a three-year period at the two hospitals were included in the analysis. Our
main outcome measure was the percentage of patients with episodes of hypoxemia (SpO2 < 90) or
severe hypoxemia (SpO2 ≤ 85) for two minutes or longer during the intraoperative period
(induction of anesthesia, surgery, and emergence).

Correspondence to: Jesse M. Ehrenfeld, [email protected].


Author contributions: Dr. Ehrenfeld had full access to all of the data in the study and takes responsibility for the integrity of the data
and the accuracy of the data analysis.
Study concept and design: Ehrenfeld, Gawande, Funk.
Acquisition of data: Ehrenfeld, van Schalkwyk.
Analysis and interpretation of data: Ehrenfeld, Funk, Gawande, Sandberg, Merry, van Schalkwyk.
Drafting of the manuscript: Ehrenfeld, Funk.
Critical revision of the manuscript for important intellectual content: Sandberg, Merry, Gawande, van Schalkwyk.
Conflicts of interest Dr. Merry has a financial interest in Safer Sleep LLC, a manufacturer of anesthesia information management
systems.
Ehrenfeld et al. Page 2

Results—We evaluated 95,407 electronic anesthesia records at the two hospitals. During the
intraoperative period, 6.8% of patients had a hypoxemic event, and 3.5% of patients had a severely
hypoxemic event of two consecutive minutes or longer. Seventy percent of the hypoxemic
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episodes occurred during either induction or emergence— time periods that represent 21% of the
total intraoperative time. From induction to emergence, one episode of hypoxemia occurred every
28.9 hr, and one episode of severe hypoxemia occurred every 55.7 hr of intraoperative time.
Conclusion—Despite advances in monitoring technology, hypoxemia continues to occur
commonly in the operating room and may be a serious safety concern because of its potential
impact on end organ function and long-term outcomes. Further studies are needed to improve our
understanding of the clinical impact of intraoperative hypoxemia and the strategies that will be
most useful in minimizing its occurrence.

Hypoxemia is recognized as one of the most serious risks patients face during anesthesia and
surgical care. Pulse oximetry has become an essential component of operating room
technology to detect, treat, and reduce the degree of intraoperative hypoxemia in the
developed world.1 Pulse oximetry has been endorsed by the Canadian Anesthesiologists'
Society, American Society of Anesthesiologists (ASA), World Federation of Societies of
Anaesthesiologists, and the World Health Organization as a minimal monitoring standard
during surgery.2-5 Before the widespread adoption of pulse oximetry in the 1980s and the
establishment of anesthesia monitoring standards in the 1990s, hypoxemia was the leading
cause of anesthesia-related mortality.6,7 Since then, anesthesia-related mortality has dropped
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nearly 20-fold in developed settings.8-10 Much of this decline is attributable to


improvements in the safety of anesthesia administration and monitoring, including the
nearly universal use of pulse oximetry that has been associated with the earlier diagnosis and
correction of hypoxemia.7,11-14

With the decline in anesthesia-related mortality, we have focused our attention on


understanding the long-term effects of exposure to anesthesia.15 One area of great
uncertainty is the clinical impact of transient hypoxemia during surgery. To date, no
published studies using current-generation pulse oximetry technology have characterized the
incidence or severity of hypoxemia during surgery. Additionally, the clinical impact of
transient intraoperative hypoxemia on outcomes such as surgical site infections,
postoperative cognitive dysfunction, and other end organ dysfunction, such as myocardial
and renal insufficiency, has not been studied.

The recent advent of electronic anesthesia record keeping systems16-18 that automatically
record intraoperative physiologic parameters has made it possible, for the first time, to
examine pulse oximetry data from a large number of surgical patients during routine care.
Therefore, the aim of this retrospective study was to utilize electronic intraoperative records
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to determine the incidence, severity, and duration of hypoxemia in a large population of


surgical patients at two major academic medical centres.

Methods
Following approval of the study protocol by the Institutional Review Boards of two large
academic tertiary hospitals— both with active transplant programs and surgical volumes in
excess of 40,000 cases annually— electronically recorded pulse oximetry data were
obtained from the anesthesia information management systems at both centres utilizing a
structured query language. Data were collected over a three-year period (Hospital A: April
2006 to April 2009; Hospital B: November 2005 to January 2009) for each patient who
underwent general anesthesia and for whom a completed electronic anesthesia record was
available.

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Ehrenfeld et al. Page 3

For each patient, the database query returned all pulse oximetry values, patient
demographics (age, sex, American Society of Anesthesiologists' [ASA] physical status
classification), surgical procedure, and case duration. Pediatric patients (age < 16 yr),
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patients undergoing cardiopulmonary bypass, and procedures performed outside of the


operating room (e.g., magnetic resonance imaging, endos-copy, radiology) were excluded
from the study. Case milestones (induction of anesthesia, start of surgery, end of surgery,
patient departure from the operating room) were also obtained from the electronic anesthesia
databases in order to separate pulse oximetry signals into discrete case phases.

Current generation pulse oximeters (Hospital A: Radical 7 - Masimo, Irvine, CA, USA;
Hospital B: Nellcor - Boulder, CO, USA) utilizing conventional red and infrared
photoplethysmography, digital signal processing, and adaptive filtration were used during
the study period. The pulse oximeters were configured to provide either an eight-second
(Hospital A) or 20-sec (Hospital B) average of oxygenation (SpO2) values. This information
was polled by the information management systems either every 60 sec (Hospital A) or
every 30 sec (Hospital B). All values recorded by the information management systems
were included in the analysis.

We calculated the number and duration of episodes of both hypoxemia (SpO2 < 90) and
severe hypoxemia (SpO2 ≤ 85) for each patient. We chose these definitions on the basis of
the accepted definition of hypoxemia (SpO2 < 90 that correlates with a PaO2 of < 60 mmHg)
and previous studies that have defined severe hypoxemia as SpO2 ≤ 85.12,19,20 Episodes of
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hypoxemia and severe hypoxemia were then categorized according to maximum duration
per patient and according to the phase of intraoperative care during which they occurred:
induction of anesthesia to start of surgery (induction), start of surgery to end of surgery
(surgery), or end of surgery to departure from the operating room (emergence).

When calculating episode durations, we categorized hypoxemic events as lasting one, two,
three, four, five, or ≥ six minutes. We treated each individual value recorded in the
anesthesia information management systems as persisting until replaced by a new value.
Thus, at Hospital A, two consecutive abnormal values sampled every 60 sec represented a
two-minute hypoxemic episode. Three consecutive abnormal readings represented a three-
minute hypoxemic event. At Hospital B, four consecutive abnormal values sampled every
30 sec represented a two-minute hypoxemic episode, while six consecutive abnormal values
represented a three-minute hypoxemic event. In order to allow comparison of data between
Hospital A and Hospital B, episodes at Hospital B that consisted of an odd number of values
were divided evenly into adjacent bins (e.g., the group of patients with three consecutive
abnormal values representing 1.5 min was split evenly into either the one-minute bin or the
two-minute bin). In order to understand the effect of our treatment of the odd number of
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consecutive readings at Hospital B, a sensitivity analysis was performed by modelling the


effects of downscaling data recorded at 30-sec intervals into data recorded at one-minute
intervals using a Weibull distribution.

For each episode of hypoxemia and severe hypoxemia that lasted two minutes or longer, we
then calculated the average number of hours between instances. Our goal was to report how
often providers encounter hypoxemia in routine practice. We performed this calculation only
on episodes that lasted two minutes or longer, because we wished to increase our specificity
for detecting episodes that were truly reflective of hypoxemia by including episodes where
multiple abnormal SpO2 recordings occurred sequentially—and excluding non-consecutive
readings that might be more reflective of artefact.

Mean age, sex, ASA physical status classification, number of emergency cases, and average
surgical times for the entire sample were also calculated. To validate the accuracy of the

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Ehrenfeld et al. Page 4

electronic data query, a random sample of print-outs of anesthesia information management


system records from 100 patients at each hospital was manually compared with the
information returned from the data query.
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Results
Our search returned data from 245,458 completed electronic anesthesia records, and 95,407
of those met our inclusion criteria (Hospital A: 55,775; Hospital B: 39,632). The majority of
cases excluded from our sample (52%) failed to meet our age criteria (≥ 16 yr), with another
large sample (33%) representing cases performed under regional anesthesia or monitored
anesthesia care. The case demographics are shown in Table 1. The average age and sex
distributions were similar between Hospital A and Hospital B. The ASA physical status
distributions revealed a larger percentage of patients with no medical co-morbidities (i.e.,
ASA I) at Hospital B compared with Hospital A (36.4% vs 15.7%, respectively), but the
number of patients rated ASA I or II was very similar (71.5% vs 71.6%, respectively).
Finally, the mean surgical times at Hospital A were moderately longer than those at Hospital
B (107 min vs 73 min, respectively).

The total distribution of pulse oximetry values returned by the data query for both hospitals
is shown in Fig. 1. Of the 15,985,965 SpO2 readings, 99.63% were within the normal range
(≥ 90%) and 0.37% of all readings represented values < 90%. Additionally, as shown in Fig.
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1, the values 99% and 100% represent the majority (56%) of all readings. The occurrence of
hypoxemic events was associated with higher ASA physical status.

Table 2 shows the relative timing of hypoxemic episodes of all durations, lists the
percentage of patients experiencing hypoxemia and severe hypoxemia during the three
phases of intraoperative care, and shows the mean duration of each of the three time
intervals. During each of the three time intervals, i.e., induction, surgery, and emergence, a
similar percentage of patients experienced hypoxemia (7.4%, 7.2%, and 9.3%, respectively)
and severe hypoxemia (4.1%, 3.8%, and 5.4%, respectively). Patients spent almost eight
times longer in the surgical phase (93 min mean duration) as they did in either the induction
or emergence time periods (mean duration 12 min each).

The incidence and duration of intraoperative hypoxemic episodes are shown in Fig. 2, with
details by hospital shown in the Appendix. The episodes are grouped by maximum duration
per patient for both hypoxemic (SpO2 < 90) and severely hypoxemic (SpO2 ≤ 85) episodes.
The percentage of patients experiencing hypoxemia or severe hypoxemia for two minutes or
longer was 6.8% and 3.5%, respectively, and the percentage of patients who were
hypoxemic or severely hypoxemic for five consecutive minutes or longer was 1.6% and
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0.8%, respectively. In our sample, the average intraoperative time between each two-minute
or longer episode of hypoxemia and severe hypoxemia was 28.9 hr and 55.7 hr, respectively.
The overall rate of hypoxemia was stable over the three-year period examined at both
centres. The manual comparison of print-outs of the records yielded 100% concordance with
the electronic data queries performed at each hospital, confirming our confidence in data
extraction methodology. Finally, the sensitivity analysis of the impact of splitting data from
Hospital B into adjacent 60-sec intervals revealed a small degree of error, suggesting that
our approach was a reliable method for joining the two data sets.

Discussion
Summary of findings
Our data revealed that 6.8% of patients were hypoxemic and 3.5% were severely hypoxemic
for two consecutive minutes or longer during the intraoperative period. Among the SpO2

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Ehrenfeld et al. Page 5

readings reflective of hypoxemia, episodes appeared to be relatively evenly divided among


the three phases of intraoperative care, even though the induction phase (average time 12
min) and emergence phase (average time 12 min) were significantly shorter than the surgical
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phase (average time 93 min). From induction to emergence, an anesthesia provider in a


tertiary care centre can expect to manage a period of hypoxemia of two-minute duration or
longer at least once every 29 hr of intraoperative time.

Comparison with previous reports


Our findings are consistent with previous studies12,21-23 that have suggested that
intraoperative hypoxemia occurs at a significant rate. The largest randomized evaluation of
pulse oximetry23 revealed a combined incidence of hypoxemia in the operating room and
postanesthesia care unit of 7.9% (n = 10,312), although it did not define the duration of
hypoxemic episodes and used first generation pulse oximetry technology that is subject to
additional signal artefact (Nellcor N-200, Ohmeda 3700 & Radiometer OXI). It appears that
our results are generalizable, given the similarity between our results and this previous work,
the large number of patients included in our study, and the similarity of results between our
two centres (see Appendix).

The finding that 70% of hypoxemia occurs during only one-fifth of the time spent in the
operating room is consistent with our clinical experience, which suggests that the time close
to induction of anesthesia and emergence are particularly high-risk periods for hypoxemia.
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This intuition is supported by data from the ASA Closed Claims database, which has shown
that difficult airway claims continue to comprise the highest percentage of claims.24 The
majority of these claims are related to incidents that occurred during induction (67%), with
similar numbers occurring during surgery (15%) and extubation (12%).25

Implications
Our data suggest that a surprisingly high percentage of patients experience sustained
hypoxemia during surgery. Even in highly advanced surgical settings, approximately one in
15 patients experienced hypoxemia for at least two consecutive minutes, and one in 64
patients experienced hypoxemia for at least five consecutive minutes. These frequencies are
likely higher in resource-limited settings throughout the world where pulse oximetry is often
unavailable, and hypoxemia may not be recognized by the perioperative team. Given that
approximately 234 million surgical procedures are performed annually worldwide,26 our
report suggests that at least three million patients each year experience prolonged (≥ five
minutes) and potentially preventable hypoxemia during surgery.

The thresholds for the duration and severity of hypoxemia that are likely to affect clinical
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outcomes are unknown, but the levels of hypoxemia reported in this study may have a
clinical impact. Although the effect of oxygen saturation levels on surgical patient morbidity
has been studied in several clinical trials, little has been published on the impact of transient
hypoxemic events on surgical outcomes. Reduced cerebral oxygen saturation levels have
been correlated with higher postoperative complication rates in thoracic surgery.27
Perioperative administration of supplemental oxygen has been shown to reduce the
incidence of surgical-wound infections,28,29 to improve immune function,30 and to decrease
the incidence of postoperative nausea and vomiting.31 Furthermore, hypoxemia has been
demonstrated in a variety of animal models to have detrimental effects on almost every end
organ.32 At the cellular level, hypoxia has been shown to lead to acute heart failure,33
pulmonary hypertension,34 and acute renal failure.35 Hypoxia-induced changes in neural
tissue have been associated with decreased cognitive function.36 Additionally, numerous
studies have demonstrated that even modest fluctuations in oxygen delivery may lead to
cognitive dysfunction.37 One study has linked intraoperative desaturation (measured by

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cerebral oxygen monitoring) with a decline in postoperative cognitive function (POCD).38


In that study, patients who experienced a drop in cerebral oxygen levels of ≥ 25% were
found to have a statistically significant decline in their Mini Mental State Examination
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scores measured seven days after surgery. Although the predictors of POCD are still not
well understood, further examination of the impact of transient hypoxemia on POCD is
warranted, because 5-12% of patients demonstrate POCD at three-month follow-up visits.39

The evidence base for the use of pulse oximetry has been questioned in previous studies.40
However, even the largest prospective randomized controlled trial of pulse oximetry23,41
was insufficiently powered to reveal a mortality benefit from pulse oximetry (nearly two
million patients would have been required). Furthermore, a post-hoc analysis of this trial41
suggests that the use of pulse oximetry was associated with several key benefits, including a
reduction in myocardial ischemia (from 0.2 to 0.1%; P = 0.03) and cardiac arrest (from 0.1
to 0.04%; P = 0.06). Endobronchial intubation and hypoventilation were also recognized
more frequently.42

These clinical data and animal model studies suggest only that the hypoxemia we observed
during surgery may have been clinically relevant. They do not establish a direct link
between perioperative hypoxemia and poor clinical outcomes. However, as the oxygen-
hemoglobin dissociation curve indicates, there is little reserve when saturations fall to <
90%, let alone 85%; undoubtedly, there is a threshold below which hypoxemia causes
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survivable end organ damage. The potential public health impact of our findings is difficult
to quantify, but given the very large numbers of patients undergoing surgery with anesthesia
globally, it may well be substantial.

Limitations
Our data were derived objectively from routine clinical practice at two geographically
distinct centres and demonstrate real-world validity by eliminating the biases often
associated with study observation. However, the retrospective nature of our study does limit
the conclusions we can draw. Specifically, our data do not provide information on the
etiology of the episodes of hypoxemia, and we also lack data on patient outcomes.

Pulse oximeters have well-known technical limitations and various sources of artefact that
may have influenced the quality of our data.43 Sensor malposition can lead to apparent
hypoxemia; the incidence of this is unknown, but such artefacts are thought to be rare.44
Poor peripheral perfusion, hypothermia, hypotension, and advanced age have been shown to
yield low-quality pulse oximetry readings.45

Since our study was a retrospective analysis of current practice, we were unable to compare
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our electronically recorded data with actual plethysmographic signals or to estimate the
specific performance characteristics of the devices used in the study. However, pulse
oximeters have been validated previously in multiple clinical trials,46-49 including several
within the perioperative environment.50-52 These studies have shown that current generation
pulse oximeters provide reliable readings when compared with arterial blood gas sampling –
even in the circumstances with poor peripheral perfusion, hypothermia, and motion.50,51,53
All of the pulse oximeters used in the study adhere to the International Organization for
Standardization (ISO) standards for pulse oximetry accuracy.54

We attempted to minimize the impact of spurious readings on our results in two ways. First,
we validated our hypoxemia data on 200 randomly selected patients. The concordance
between the data returned by the electronic query and the patients' anesthesia records was
100%, providing considerable reassurance in relation to our algorithms. Second, we focused
on the percentage of patients who experienced episodes of hypoxemia that lasted two

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Ehrenfeld et al. Page 7

minutes or longer. We chose this interval because it ensured that each hypoxemic episode
represented at least two consecutive abnormal readings - as opposed to single isolated
values. While there is no standardized definition of what constitutes a hypoxemic episode
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under anesthesia, we believe that the selection of this interval strikes an appropriate balance
between capturing events that are likely to be reflective of true hypoxemia and eliminating
isolated spurious values. Additionally, in our practice, we consider any episode of
hypoxemia that lasts at least two minutes to be clinically significant.

Since our data were recorded every 30 or 60 sec rather than continuously, they could have
been subject to an undersampling artefact because a single value was used to summarize a
series of values over a discrete time interval.55,56 Thus, undersampling may have
underestimated the true frequency of hypoxemic episodes. However, since our sampling
intervals were either 30 or 60 sec, such episodes would be sub-minute episodes of uncertain
clinical significance. On the other hand, we treated each single value as being representative
of the entire time interval over which it was recorded. This may have either over- or
underestimated the duration of any given hypoxemic episode. Despite this possibility, we
believe our methodology represents a logical compromise between these two competing
concepts and aligns with the interpretation of these data points in clinical practice.

Finally, although pulse oximetry data were collected automatically by electronic systems
without user intervention, the case milestones (i.e., induction of anesthesia, start of surgery,
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end of surgery, and departure from operating room) were manually entered events and, as
such, may be subject to errors in data entry, for example, event latency.57 Furthermore, there
is no universal definition for these events, although attempts have been made at
standardization of anesthesia procedural times.58 While a discrepancy in case times might
lead to the misclassification of the case phase for a particular hypoxemic episode, it would
not affect the overall SpO2 data.

Conclusions
Anesthesia providers strive to avoid hypoxemia because of the risk of irreversible damage to
the myocardium, brain, and other end organs. Despite these efforts, hypoxemia continues to
occur in the operating room at a surprisingly high rate. This may represent a serious safety
concern because of its potential impact on end organ function and long-term outcomes. Our
findings suggest that a typical anesthesia provider is likely to encounter at least one episode
of sustained (≥ two minutes) hypoxemia every 29 hr of intraoperative time. In the
developing world where pulse oximetry is not universally available, hypoxemic episodes
may well be more frequent and longer. Future studies that focus on whether these episodes
are preventable and have a clinical impact are warranted.
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Acknowledgments
Financial support for the preparation of this manuscript was provided from department funds of the Department of
Anesthesia, Critical Care & Pain Medicine, Massachusetts General Hospital and from 5T32GM007592 from the
National Institute of Health.

Appendix
The figures below show the incidence and duration of intraoperative hypoxemic episodes by
hospital. Episodes are grouped by maximum duration per patient for both hypoxemic (SpO2
< 90) and severely hypoxemic episodes (SpO2 ≤ 85).

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Fig. 1.
Distribution of All SpO2 Readings. The distribution of SpO2 readings from the 95,407
anesthesia cases. Of the 15,985,965 SpO2 readings, 99.63% were within the normal range (≥
90%) and 0.37% of all readings represented values < 90%
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Ehrenfeld et al. Page 13
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Fig. 2.
Duration of Hypoxemic Episodes at Hospitals A & B. The incidence and maximum duration
of intraoperative hypoxemic episodes. Episodes are grouped by maximum duration per
patient for both hypoxemic (SpO2 < 90) and severely hypoxemic episodes (SpO2 ≤ 85). The
percentage of patients experiencing two consecutive minutes or longer of hypoxemia and
severe hypoxemia was 6.8% and 3.5%, respectively
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Ehrenfeld et al. Page 14

Table 1
Patient demographics
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Hospital A Hospital B
(n = 55,775) (n = 39,632)

Mean age (yr)


(standard error) 53.4 (0.07) 48.3 (0.10)
Sex (%)
Male 46% 45%
Female 54% 55%
ASA physical status (%)
1 15.7% 36.4%
2 55.8% 35.0%
3 24.4% 22.6%
4 2.6% 4.1%
5&6 0.1% 0.1%
Unknown 1.5% 1.8%
Emergency cases (%) 4.7% –
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Surgical time (min).


Mean (standard error) 107 (0.4) 73 (0.4)

ASA = American Society of Anesthesiologists


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Table 2
Incidence and timing of hypoxemia
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Hospital A and B (n = 95,407) Induction of anesthesia to Start of surgery to end of End of surgery to exit OR
start of surgery surgery

Mean duration of each interval 12 min 93 min 12 min


Patients with hypoxemia (SpO2 < 90) n (%) 7,101 (7.4%) 6,908 (7.2%) 8,875 (9.3%)

Patients with severe hypoxemia (SpO2 ≤ 85) n 3,954 (4.1%) 3,582 (3.8%) 5,157 (5.4%)
(%)

OR = operating room
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