Journal of Critical Care 47 (2018) 238–244

Contents lists available at ScienceDirect

Journal of Critical Care

journal homepage: www.journals.elsevier.com/journal-of-critical-care

Safety incidents in airway and mechanical ventilation in Spanish ICUs:

The IVeMVA study☆
Ángela Alonso-Ovies a,⁎, Nicolás Nin b, Maria Cruz Martín c, Federico Gordo d, Paz Merino e, José M. Añón f,
Blanca Obón g, Mónica Magret h, Isabel Gutiérrez g, and IVeMVA study investigators 1
a
Department of Intensive Care Medicine, Hospital Universitario de Fuenlabrada, Madrid, Spain
b
Department of Intensive Care Medicine, Hospital Español, Montevideo, Uruguay
c
Department of Intensive Care Medicine, Hospital Universitario de Torrejón, Madrid, Spain
d
Department of Intensive Care Medicine, Hospital Universitario del Henares, Coslada, Madrid, Spain
e
Department of Intensive Care Medicine, Hospital Can Misses, Ibiza, Spain
f
Department of Intensive Care Medicine, Hospital Universitario La Paz-Carlos III, IdiPAZ, CIBERES, Instituto de Salud Carlos III, Madrid, Spain
g
Department of Intensive Care Medicine, Hospital Clínico, Zaragoza, Spain
h
Department of Intensive Care Medicine, Hospital Universitario Joan XXIII, Tarragona, Spain

a r t i c l e i n f o a b s t r a c t

Available online xxxx Purpose: To assess incidence, related factors and characteristics of safety incidents associated with the whole pro-
Keywords: cess of airway management and mechanical ventilation (MV) in Spanish ICUs.
Patient safety Materials and methods: Observational, prospective, 7 days cross-sectional multicenter study. Airway and MV re-
Adverse events lated incidents were reported using structured questionnaire. Type, characteristics, severity, avoidability and
Mechanical ventilation contributing factors of the incidents were assessed.
Intensive care unit
Results: Participant ICUs: 104. Inclusion of 1267 patients; 745 (59%) suffered one or more incidents. Incidents re-
Incident reporting and analysis
ported: 2492 (59% non-harm-events, 41% adverse events).
Individual risk of suffering at least one incident: 66.6%. Incidence ratio (median) of incidents: 2 per 100 patient-
hours. 73.7% of incidents were related to MV process, 9.5% to tracheostomy, 6.2% to non-invasive MV, 5.4% to
weaning/extubation, 4.4% to intubation and 0.8% to prone position.
Temporary damage was produced in 12% incidents, while 0.8% was related to permanent injuries, risk to the
patient's life or contributed to death.
Incidents were considered avoidable in 73.5% of cases. 98% of all incidents had 1 or more contributing factors.
Conclusions: MV is a risk process in critical patients. Although most incidents did not harm patients, some caused
damage and a few were related to the patient's death or permanent damage. Preventability is high.
© 2018 Elsevier Inc. All rights reserved.

1. Introduction
Management of airway and mechanical ventilation (MV) is one of
the most common procedures in ICU. Although the percentage of pa-
tients needing MV varies depending on the studies and the specific
characteristics of each ICU, it is estimated to oscillate between 40 and
Abbreviations: ICU, Intensive Care Unit; MV, Mechanical ventilation; AE, Adverse
Event; NHE, Non-harm event; NIMV, non-invasive mechanical ventilation.
☆ This research did not receive any specific grant from funding agencies in the public,
commercial, or not-for-profit sectors. This study has received the scientific endorsement
of the Spanish Society of Intensive Medicine (SEMICYUC).
⁎ Corresponding author at: Department of Intensive Care Medicine, Hospital
Universitario de Fuenlabrada, Camino del Molino 2, 28492 Fuenlabrada, Madrid, Spain.
E-mail address: a.alonso@salud.madrid.org (Á. Alonso-Ovies).
1
IVeMVA study investigators are listed in ANNEX 5, in Supplementary data.
50% of admissions [1-4]. Moreover, respiratory failure and need for
MV constitutes one of the principal reasons for admission to ICU [5, 6].
The MV process in critical patients is complex, invasive, and fraught
with multiple interactions. This process encompasses a series of phases
in which dynamism and interventionism are of utmost importance.
This, coupled with the frequent severity of the patient's condition,
may produce a multitude of incidents that put patient safety at risk re-
garding potential or real harm which may trigger severe sequelae or
even death.
To date, there have been few published studies on incidents related
to MV and airway in ICU. There have been more studies published on
the subject of surgical anaesthesia, mainly regarding intubation and air-
way management [7-11]. In intensive care, much of the data is derived
from multicenter patient safety studies (ICUSRS [12], SEE [13], SYREC
[14]), or from an individual center [15], or from international epidemi-
ological studies on MV that do not contain a detailed analysis of

https://doi.org/10.1016/j.jcrc.2018.07.012
0883-9441/© 2018 Elsevier Inc. All rights reserved.
 Á. Alonso-Ovies et al. / Journal of Critical Care 47 (2018) 238–244
problems concerning patient safety [16, 17]. Other ICU studies focus on
some of the phases of the process (principally on airway management)
without seeking out incidents from the rest of the phases [18-21].
The objective of the IVeMVA study (Spanish acronym for “Incidents
involving Mechanical Ventilation and Airway”) is to learn about the in-
cidence of non-harm events (NHEs) and adverse events (AEs) related to
the whole process of airway management and MV in Spanish ICU, and
also to analyze the types of incidents that occur, their severity,
avoidability, the professionals who report them, communication with
family members and contributing factors.
2. Method
2.1. Design
7-day observational, multicenter study in a prospective cohort car-
ried out from 24/03/2014 to 30/03/2014. During this period, safety inci-
dents related to airway and MV were voluntarily and anonymously
collected by any ICU professional (specialist doctors, residents, nurses,
nurses' aides, etc.). The principal researchers (intensivists experts in pa-
tient safety and MV from the Spanish Society of Intensive Care Medicine,
“SEMICYUC”) had previously consensually compiled a list of the most
common safety incidents related to airway and MV and classified
them in six groups: airway intubation, invasive MV, MV in prone posi-
tion, weaning/extubation, tracheostomy (technique and management)
and non-invasive MV (NIMV). (Annex 1).
2.2. Context
All ICU of both public and private Spanish hospitals were invited to
participate by email, by the SEMICYUC webpage and by the Electronic
Journal of Intensive Medicine (REMI).
2.3. Inclusion criteria
Patients over 18 years, who were already hospitalized or were ad-
mitted during the course of the study, were in need of MV (invasive or
non-invasive) or were in the weaning phase (including those who
were breathing spontaneously but with airway isolation by means of
endotracheal tube or tracheal cannula), regardless of whether ventila-
tion support was initiated prior to or during the period under study.
2.4. Definitions
Those proposed by the World Health Organization were used [22]:
- Incidents related to Patient safety: events or circumstances that
could have resulted in or did result in unnecessary harm to the pa-
tient.
- NHEs: Events which did not inflict harm on the patient, either be-
cause they did not impact him/her directly or if they did, were with-
out consequences.
- AEs: events that (unintentionally) caused harm to the patient and
occurred either during or as a result of health care attention, and
no related to the course or possible complications of the patient's
base illness.
2.5. Variables studied
The variables collected were relative to hospital/ICU, patients, MV
and incidents (Annex 2). Classification of severity of incidents followed
an adaptation of the Ruiz-Jarabo group's “Classification of medication
errors” [23] (Annex 3). Contributing factors were collected according
the model proposed by the National Patient Safety Agency of the
United Kingdom [24] (Annex 4).
239
2.6. Procedure
A notebook was designed for data collection, containing instructions
for registering data and incidents that might occur to patients. A physi-
cian and a nurse were designated as coordinators in each ICU to train all
the healthcare ICU professionals in the procedures of the study (with
educational material provided by the main researchers), to control the
data collection and to complete the web electronic data base.
2.7. Data quality control
The incidents registered were reviewed by the study's main re-
searchers. Duplicate data were eliminated by consensus and all data
not considered correctly classified was reclassified.
2.8. Statistical analysis
The following absolute values were obtained for each center: num-
ber of total events (NHE and AE) associated with MV and AWM as
well as the rest of the study's variables. For each of the incidents
(NHE/AE) the risk (accumulated incidence) and rate (density of inci-
dence) were calculated.
Data are expressed as the mean ± standard deviation, the median
with the interquartile range, and proportions (absolute and relative fre-
quencies) as appropriate. Student's t-test or the Mann–Whitney test
was used to compare continuous variables, while the χ2 test or Fisher's
exact test was used to compare proportions. A p value of b0.05 was con-
sidered to show a statistically significant difference. Version 19.0 of the
IBM SPSS program was used for statistical treatment of data.
2.9. Confidentiality and ethical aspects
Compliance with the laws and guidelines on protection of personal
data was guaranteed and the anonymity and confidentiality of the inci-
dents registered was maintained. Treatment of the information ob-
tained did not allow identification of the center, reporting professional
or patient.
The project was approved by the Ethics Committee of Clinical Re-
search of Aragón (CEICA) on 26/02/2014 (code C.P.-C.I. PI14/0022)
and by each of the local Clinical Research Ethics Committees.
3. Results
One hundred and four (104) ICUs participated in the study (83.6%
polyvalent, 10.6% mixed, 5.8% monographic) from 94 hospitals out of a
total 237 Spanish hospitals with at least one ICU [25] (39.7%). The char-
acteristics of the participating ICU are reflected in Table 1.
A total of 1267 ICU patients were included out of the 2486 hospital-
ized during the week of the study (51%, CI 95% 49.1–52.9), 64.2% male,
with a median age of 63.4 (SD 14.31). The total number of days of MV
or airway isolation was 4491.5 days. Eighty seven (87) patients (7%, CI
95% 5.6–8.4) received NIMV; and 338 patients (27%, CI 95% 24.6–29.4)
were tracheostomized (tracheostomy was performed on 83 patients
−25%- during the week of the study). Types of patients, reasons for
MV and site of airway intubation are shown in Table 2. MV or airway in-
tubation was initiated during the week of the study in 575 patients
(45.4%, CI 95% 42.6–48.1).
Two thousand four hundred ninety two (2492) incidents (1475 NHEs,
1017 AEs), involving 745 patients, were reported; in other words,
58.8% of the patients (CI 95% 56.2–61.5) suffered 1 or more incidents.
The mean was 1.96 incidents/patient (SD 3.06) and the median was 1
incident/patient (IQR 0–2). The median ratio was 1.68 incidents per pa-
tient (IQR 0.9–2.8) (1 NHE, 0.5 AE) with an incidence ratio of 2 incidents
per 100 patients and per hour of MV or airway isolation (IQR 1.1–3.9) (1.2
NHE, 0.6 AE). The risk of suffering at least an event for undergoing MV or
airway isolation was 66.6% (IQR 47–83) (48.5% NHE, 38.9% AE). 21% of
240 Á. Alonso-Ovies et al. / Journal of Critical Care 47 (2018) 238–244

Table 1
Characteristics of participating ICU.

ICU size n (%) Polyvalent unit Ratio pat/nurse (mean) Staff morning shift (mean) Staff evening shift (mean) Staff night shift (mean)

Small (≤9 beds) 20 (19.23%) 100% 2.35 4.05 1.10 1.00

Medium (10–14 beds) 43 (41.34%) 81.39% 2.44 5.03 1.32 1.11
Large (≥15 beds) 41 (39.42%) 78.04% 2.30 9.24 2.21 1.87

the patients suffered 1 event, 13% suffered 2 incidents, 7% 3incidents,
5.4%, 4 incidents, and 12.5% of the patients 5 or more incidents.
The mean number of hours of MV/Airway-isolation in patients not
suffering events (n 522, 41.2%) was 52.73 h (SD 59.09) (median 24 h,
IQR 7–82) compared to the patients suffering 1 or more incidents, for
whom the mean was 106.55 h (SD 62.28) (median: 120 h, IQR 46–
168) (p b 0.001).
The majority of events reported were in the MV group (n = 1836,
73.7%, CI 95% 72–75.4), followed by those related to tracheotomy
(9.5%, n = 237), the related to non-invasive MV (6.2%, n = 155),
weaning/extubation (5.4%, n = 135), airway intubation (4.4%, n =
110) y finally those related to MV in prone position (0.8%, n = 19)
(Fig. 1).
The incidents reported for each group are reflected in Table 3.
The majority of incidents (n = 1303, 52%, CI 95% 50.1–53.9) were re-
ported during the morning shift, followed by afternoon/evening shift
(27%, n = 675) and night shift (21%, n = 514). Nurses reported 58.6%
of incidents (n = 1461, CI 95% 56.7–60.5), doctors 39.5% (n = 985)
(staff 34.3%, n = 854; residents 5.25%, n = 131) and nurses' aides
1.2% (n = 31). During the course of the study, a decrease in the number
of incidents reported was observed, dropping from 19.3% (n = 482) on
day 1 to 10.1% (n = 251) on the last day.
3.1. Severity
(Table 4) 1475 incidents (59%) were NHE (CI 95% 57.1–60.9) while
1017 (41%) were AE (CI 95% 39.3–42.7). In terms of the classification
used, the majority of NHE fall into category B (n = 881, 59.7% of NHE,
35.3% of the overall incidents), in other words, incidents that affected
the patient but did not inflict harm. As for AE, the majority belong to cat-
egory D, which means that the harm caused was impossible to deter-
mine (n = 702, 69% of AE, or 28.2% of the overall incidents).
Temporary damage was produced in 12% AEs, that include category E
(n = 266, 26.2% of AEs, 10.7% of the overall incidents) and category F
(n = 30, 2.9% of AEs, 1′2% of the overall incidents). Those producing per-
manent lesions, mortal risk or directly contributed to death (categories
G, H and I) made up 0.8% (n = 19). There were 2 incidents recorded
(0.08%) that either caused or contributed to the patient's death; these
were a failed extubation and an MV-related barotrauma.
Within the different phases, the moment of airway intubation, prone
maneuvers and the weaning period were the times of greatest risk for
suffering an AE (p b 0.05), during which the overall NHE/AE ratio was
inverted.
The medical staff reported more AE than the nursing staff (p b 0.05).
3.2. Avoidability
73.5% (n = 1832, CI 95% 71.8–75.2) of the incidents were considered
preventable, according to criteria of the reporting professionals. In rela-
tion to severity, the more severe the incident, the less preventable it was
considered (p b 0.05).
3.3. Information of incidents
Family members/patients were not informed of the event in 90.5% of
cases (n = 2255, CI 95% 89.4–91.6); however, information on AE was
provided more frequently than on NHE (p b 0.05).
3.4. Contributing factors
A total of 4088 contributing factors were associated with the presen-
tation of incidents (mean 1.64 CF/event, SD 0.96; median 1 CF/event,
IQR 1–2). Characteristics and distribution of contributing factors are
shown in Table 5.

4. Discussion
Table 2
Type of patients, reasons for MV, place of intubation.
The IVeMVA Project is the first multicenter study on the safety of ICU
n %
patients receiving MV carried out in Spain. The 104 participating ICUs
Type of patient represent the 40% of all Spanish ICUs, with sufficiently large diversity
Medical 698 55.09 in size and type of patients to constitute a valid representative sample.
Surgical 456 35.99
Polytraumatized 69 5.46
Patients who needed MV (invasive or non-invasive) or airway isolation
Coronary 44 3.46 represented 51% of all patients admitted to the ICU during the observa-
Cause VM tion period, data that concurs with other studies [2].
Post-surgical 355 28.01 Safety incidents related to airway management and MV represent a
Neurological 230 18.15
considerable percentage of overall ICU incidents, although the ratio is
Pneumonia/respiratory infection 187 14.76
Cardiorespiratory arrest 98 7.73 quite variable and oscillates between 8 and 10% in some multicenter
ARDSa 79 6.23 studies (SYREC [14] 10%, ICUSRS [12] 9.2%, SEE [13] 8.2%), but reaches
Heart failure 77 6.08 higher percentages in the AIMS-ICU study (20%) [26] or in the published
Polytraumatized 57 4.50 by Chacko et al. (33%) [15]. In all the above-mentioned studies, the inci-
COPDb 54 4.26
dents are related to airway and orotracheal tubes (leaks, obstructions,
Pulmonary embolism 4 0.31
Others 126 9.94 unplanned extubations).
Intubation place In the anesthetic-surgical context there are frequent reports of air-
ICU 512 40.41 way management-related incidents and less frequently have there
Operating room 388 30.62
been reports of events related to disconnections or leaks during surgery
Out-of-hospital 107 8.44
Emergency 90 7.10 or problems surging during extubation [7, 11, 12]. Some of these studies
Hospital ward 83 6.55 are based on analysis of law suits [8, 9, 27, 28].
Non-invasive MV 87 6.86 The number of specific publications concerned with safety incidents
a
ARDS: Acute respiratory distress syndrome. regarding MV in ICU is limited and the majority refer to events that
b
COPD: Chronic obstructive pulmonary disease. occur in certain phases, fundamentally in relation to airway
 Á. Alonso-Ovies et al. / Journal of Critical Care 47 (2018) 238–244
Fig. 1. Distribution of patient safety incidents related to the whole process of airway management and mechanical ventilation in each of the 6 defined groups (airway intubation, invasive
mechanical ventilation, mechanical ventilation in prone position, weaning/extubation, tracheostomy -technique and management-, and non-invasive mechanical ventilation). They are
presented in order of frequency as the total number of events and percentage (in parentheses).
management. Especially noteworthy is the number of reported inci-
dents that occur during intubation, tracheostomy and self-extubations
[18, 19]. These incidents can be associated with extreme severity and
a high risk of death or permanent brain damage [20].
The incidence rate and risk of suffering a safety event as a conse-
quence of MV or airway isolation detected in our study is not compara-
ble with those of other studies, given that IVeMVA study has collected
data relevant to the total process of MV and airway management, in-
cluding NIMV, a spectrum not reflected in other studies.
A broader view of incidents related to the whole MV process was
published by Auriant et al. in 2002 [21]. For three months in 2 French
ICU, it was registered all the incidents suffered by MV patients (except
tracheotomized) during 3 phases: intubation, MV monitoring and
weaning/extubation. The study revealed 4.12 incidents per patient,
and 0.004 incidents per day on MV and 1 AE per patient per MV episode.
The majority of incidents were found to occur during MV, which con-
curs with our study, followed by the intubation phase and weaning.
None of the events registered led to death or permanent lesions, al-
though the majority of the intubation phase incidents immediately en-
dangered the patient's life (72%) in contrast with the MV phase (14%).
The difference between the mean of incidents in the Auriant study
(4.12 incidents/patient) and that of IVeMVA (1.96 incidents/patient)
can be explained by the greater attention to safety and the level of
“safety culture” achieved in ICU in recent years as well as by the shorter
incident collection period of our study, which probably intensified the
greater attention given to patient safety in MV.
Close to 60% of the patients enrolled in IVeMVA study suffered air-
way/MV related incidents. Our data reveals a greater percentage of inci-
dents in patients who were submitted to MV for a longer time period.
That is, prolonged MV implies a risk which should alert us to the appear-
ance of possible safety incidents.
The greatest number of safely incidents occurred during the MV
phase, as would be expected, since it lasts longer than other phases (air-
way intubation or tracheotomy technique are specific one-time inter-
ventions and prone position ventilation or extubation are quite brief).
The most common event is accidental disconnection. Accidental and
self-extubation (2%, n = 37) were not as frequent as in other studies
[12, 15, 18]. Of special note during this phase is the percentage of events
in which harm prevention measures are not taken, (prevention of
ventilator-associated pneumonia 16.4%, alarm prescription 15.4%, seda-
tion monitoring 5%, protective MV during respiratory distress, 0.9%).
This type of incidents, generally caused by errors of omission, are classi-
fied as category D of severity, where the degree of harm caused is im-
possible to directly determine, even though it's clear that failure to
apply the optimal practice must have inflicted some harm. Recently
there have been published tools that facilitate the detection of this
241
type of errors, as the AASTRE study [29]. Adequate MV training can
also decrease this type of AEs. Recent studies have revealed that MV rec-
ommendations regarding protective ventilation are often not followed
[30].
Only 11.8% of patients included in the study were intubated in the
ICU during the data collection period. While the number of such inci-
dents is not very high (4.4%), they do entail greater severity. AEs pre-
dominate over NHEs, with temporary harm caused in 43% of events
and permanent harm or risk of death in 3%. However, in airway intuba-
tion related incidents no death was reported. The incidents registered in
this group were similar to those referred to in other studies [21, 31]: he-
modynamic instability, followed by delay in intubation, esophageal in-
tubation and selective intubation of the right main bronchus.
Tracheotomy is a source of potentially life-threatening events, not
only during the performance the technique itself, whether percutane-
ous or surgical [32-34], but also during subsequent cannula manage-
ment [35], because of obstructions, displacements, etc. In our study, it
is also shown that this group of events contains the highest percentage
of severe AE: 7 incidents (2.9%) were deemed life-threatening (6 related
to cannula management and 1 to performance of the technique).
Incidents related to prone position were rare, as is proportionate to
the small number of prone maneuvers; therefore the results are not re-
ally significant. The high ratio of AE in this group is associated with the
fact that 50% of the reported events belong to group E (temporary harm
calling for intervention), the majority of which were pressure ulcers
(42%, n = 8). Disconnections and orotracheal tube obstructions were
common as well, but no related severe AE or deaths were reported.
These data coincide with those published by Lee et al. [36].
In the weaning phase, what is striking is the number of events re-
lated to the delay in carrying out spontaneous breathing tests (n =
21) or protracted unjustified weaning (n = 13) which lengthened intu-
bation time. There are also numerous failed extubations, which ended
up requiring early reintubation (n = 25). All these incidents highlight
the importance of implementing weaning protocols, with spontaneous
awakening trials and spontaneous breathing trials [37].
There are few studies on registered incidents of NIMV [38]. In our
study, there were 155 reported incidents among the 87 patients who re-
ceived NIMV. The majority (47.7%, n = 74) of these incidents involved
leaks, inadequately sealed face masks, accidental disconnections and re-
moval of the facemask by patient, all with no harm to the patient. There
were no severe AE reported. The most severe events were facial lesions
secondary to the pressure of the face mask (n = 18) and 2 episodes of
broncoaspiration.
The professionals reporting the greatest number events were the
nurses, similarly than in other studies [14], given that they are the
staff members who spend the most time with patients. However, the
242 Á. Alonso-Ovies et al. / Journal of Critical Care 47 (2018) 238–244

Table 3 Table 3 (continued)

Incidents reported for each group.
n %
n % section
section
Accidental oxygen disconnection (T-tube/mask) 30 12.7%
Group 1. Airway intubation (AWI) incidents (n = 110, 4.4% of the total) Self-disconnection of tubing/O2 by the patient 26 11.0%
Hemodynamic instability 24 21.8% Self-withdrawing of the cannula 15 6.3%
Delay in the intubation of the airway 21 19.1% Accidental withdrawal of the cannula 14 5.9%
Intubation in the esophagus 17 15.5% Desaturation/hypoxia related to the tracheostomy technique 13 5.5%
Selective intubation of right bronchus 14 12.7% Air leak related to the tracheostomy technique 9 3.8%
Air leak due to incorrect position of the orotracheal tube 8 7.3% Bronchoaspiration 8 3.4%
Bronchoaspiration 5 4.5% Peritracheal bleeding not directly related to the technique 7 3.0%
Damage to the structures of the mouth (rupture/loss of teeth …) 5 4.5% Bleeding related to the tracheostomy technique 5 2.1%
Cardiac arrhythmias 3 2.7% Failure in decannulation/early recannulation 4 1.7%
Urgent tracheostomy or cricotiroidomy 2 1.8% Errors in VM disconnection 4 1.7%
Injury to pharynx/larynx/trachea (tearing, perforation, bleeding) 1 0.9% Impossibility of recannulation 3 1.3%
Need for urgent change of orotracheal tube due to puncture 1 0.9% Atelectasis related to the tracheostomy technique 2 0.8%
Pneumothorax/Pneumomediastinum/Subcutaneous emphysema 1 0.9% Prolonged hypoxia (anoxic encephalopathy) related to cannula 2 0.8%
Others 8 7.3% change
Group 2. Mechanical ventilation (VM) incidents (n = 1836, 73.7% of the total) False track related to the tracheostomy technique 1 0.4%
Accidental disconnection 493 26.9% Prolonged hypoxia (anoxic encephalopathy) related to the 1 0.4%
Failure to comply with measures of prevention of 301 16.4% tracheostomy technique
ventilator-associated pneumonia (VAP) detected at any time Pneumothorax related to the tracheostomy technique 1 0.4%
during the study Others 11 4.6%
Non-prescribed respirator alarms, poorly adjusted or not checked 282 15.4% Group 6. Non-invasive mechanical ventilation incidents (n = 155, 6.2% of the
by nursing. total)
Prolonged patient-ventilator dyssynchrony 98 5.3% Poor sealing of the interface - Leaks 47 30.3%
Deep inadequate/unmonitored sedation 93 5.1% Facial lesions due to the pressure of the mask (nasal/facial ulcers, 18 11.6%
Ventilator malfunction 67 3.6% corneal lesions)
Atelectasis 61 3.3% Tubing/mask disconnection 17 11.0%
Excessive progression of the endotracheal tube during VM days 59 3.2% Not set respirator alarms or poorly adjusted or not checked by 14 9.0%
(selective intubation of the right bronchus) nursing
Problems with circuit tubbing or filters 52 2.8% Self-withdrawing mask 10 6.5%
Endotracheal tube excessively out (leakage) 51 2.8% Dysfunction of the machine 7 4.5%
Endotracheal tube obstruction requiring no change (stopper, 33 1.8% Wrong programming 7 4.5%
patient bite) Delayed onset of non-invasive MV in exacerbation of COPD 4 2.6%
Self-extubation 28 1.5% Vomiting from gastric overdistension due to “swallowed” air 4 2.6%
Air leak due to endotracheal tube cuff deflated 27 1.5% Abdominal distension 3 1.9%
Airway mucosa injuries related to manipulation (aspiration, 24 1.3% No indication of non-invasive MV 3 1.9%
bronchoscopy) Delayed onset of invasive ventilation if indicated 3 1.9%
Endotracheal tube obstruction requiring unforeseen urgent 23 1.3% Bronchoaspiration 2 1.3%
change No availability of technique 2 1.3%
Absence of protective MV in acute respiratory distress syndrome 17 0.9% Need for over-sedation 1 0.6%
(ARDS) Others 13 8.4%
Air leak due to puncture of endotracheal tube cuff 13 0.7%
Inadequate/unmonitored neuromuscular relaxation 13 0.7%
Accidental extubation 9 0.5% most severe events were reported by doctors, as they are usually related
Barotrauma in relation to the MV (excludes the one associated 7 0.4%
to procedures or maneuvers performed by them.
with the placement of central venous catheter and/or thoracic
trauma) The decline in the number of reported events during the course of
Bronchoaspiration 7 0.4% the study could be explained by a relaxation or weariness on the part
Sequelae related to deep relaxation (polyneuropathy) 6 0.3% of the staff, added to the fact that the last two days of the data collection
Inadequate respirator programming 4 0.2%
period coincided with a weekend, when there is a reduced number of
Others 68 3.7%
Group 3. Ventilation in prone position incidents (n = 19, 0.8% of the total)
staff on duty.
Development of pressure ulcers in supporting areas in prone 8 42.1% The attending professionals themselves were the ones who con-
position cluded that the majority of incidents were preventable, which reflects
Displacement of the endotracheal tube 4 21.1% positively on their awareness of the possibilities for improving safety.
Endotracheal tube obstruction 3 15.8%
Nevertheless, the most severe events, involving death or risk of death,
Accidental disconnection 2 10.5%
Loss of devices 1 5.3% were deemed unpreventable in the majority of cases. Fear of punitive
Vomiting-bronchoaspiration 1 5.3% reprisals for severe incidents might possibly have been behind the label-
Group 4. Weaning/Extubation incidents (n = 135, 5.4% of the total) ing of these events as “not avoidable”.
Failed extubation/early reintubation 25 18.5% Patients and their family members were informed in b10% of the in-
Pharyngeal pain after extubation 21 15.6%
Failure to perform spontaneous ventilation tolerance test when 21 15.6%
cidents, which reveals the need to establish strategies that encourage
indicated open and honest information when AEs occur, especially in the more se-
Other vocal cord injuries 16 11.9% vere cases [39].
Prolonged unexplained weaning (delayed extubation) 13 9.6% The detection of a high number of contributing factors in each inci-
Subglottic edema/stridor 9 6.7%
dent, as has been reported in other studies on AE in critical patients
T-tube accidental disconnection 7 5.2%
Disconnection without meeting weaning criteria 6 4.4% [40], indicate a greater reflection on causes of incidents and a greater de-
Weaning failed 4 3.0% termination to improve patient safety for critical patients.
Precipitated extubation. Need for non-invasive MV 3 2.2%
Bronchoaspiration during extubation 1 0.7% 4.1. Limitations
Others 9 6.7%
Group 5. Tracheostomies incidents (n = 237, 9.5% of the total)
Cannula obstruction 43 18.1% As in the rest of patient safety studies based on voluntary reporting
Peritracheostomy leak 38 16.0% of incidents, there may be the risk of infra-reporting due to a lack of
knowledge of what needed to be reported, lack of awareness that an
 Á. Alonso-Ovies et al. / Journal of Critical Care 47 (2018) 238–244 243

Table 4
Distribution of safety incidents according to severity. Groups A, B and C correspond to non-harm events (NHE), while incidents of groups D, E, F, G, H and I correspond to adverse events
(AE).

Severity of incidents Total incidents

section

A B C NHE D E F G H I AE n (%)

n (% n (% n (% % NHE n (% n (% n (% n (% n (% n (% % AE
row) row) row) row row) row) row) row) row) row) row

Group 1 airway intubation 4 7 22 30 27 45 2 1 2 0 70 110

(3.6) (6.4) (20) (24.5) (40.9) (1.8) (0.9) (1.8) (0) (4.4)
Group 2 mechanical ventilation 162 700 263 61.3 573 120 12 1 4 1 38.7 1836
(88) (38.1) (14.3) (31.2) (6.5) (0.7) (0.05) (0.2) (0.05) (73.7)
Group 3 prone position 0 2 3 26.3 1 10 3 0 0 0 73.7 19
(0) (10.5) (15.8) (5.3) (52.6) (15.8) (0) (0) (0) (0.8)
Group 4 weaning/extubation 1 11 24 26.7 48 39 9 0 2 1 73.3 135
(0.7) (8.1) (17.8) (35.6) (28.9) (6.7) (0) (1.5) (0.7) (5.4)
Group 5 tracheostomy 10 87 78 73.8 23 29 3 0 7 0 26.2 237
(4.2) (36.7) (32.9) (9.7) (12.2) (1.3) (0) (2.9) (0) (9.5)
Group 6 non-invasive MV 14 74 13 65.2 30 23 1 0 0 0 34.8 155
(9) (47.7) (8.4) (19.4) (14.8) (0.6) (0) (0) (0) (6.2)
Total (% row) 191 881 403 702 266 30 2 15 2 2492
(7.7) (35.3) (16.2) (28.2) (10.7) (1.2) (0.1) (0.6) (0.1)
NHE 1475 (59.2%) AE 1017 (40.8%)

error had been committed or fear of reprisals. It should also be consid- 5. Conclusions
ered that the “Hawthorne effect” could have influenced the results,
favouring safer practices on study days and avoiding the occurrence of There are many incidents that can occur throughout all the moments
incidents. In addition, the ICUs were not selected randomly, so it may of the airway and MV management process. Their presentation corre-
be that those that participated already had a greater interest in patient lates with the number of days in MV. Although the majority of incidents
safety, which could imply a selection bias as in other studies [13, 14]. are not severe, exist moments of special risk (intubation, weaning, tra-
A week-long study period may not have been enough time to ade- cheostomy and prone position), during which it is necessary to improve
quately evaluate some of the incidents, such as those related to prone preventive measures, since most of incidents were considered avoid-
position, so further studies would be needed for this purpose. able. It should be emphasized that a high number of incidents did not
cause any obvious initial harm. These were often related to the omission
of harm-preventing measures (not applying the optimal treatment pos-
sible), being important their detection and immediate correction for
Table 5 preventing potential harm. One must also highlight the events that en-
Characteristics and distribution of contributing factors (CF) associated with events. danger patients' lives. Though their number is not high, they call for fur-
Number of CF in each incident
ther, in-depth study. Additionally, it is necessary to develop strategies to
improve information given to patients and relatives when an AE occurs
n (%)
during healthcare.
Incidents with 0 CF 57 (2.28)
Incidents with 1 CF 1341 (53.81)
Incidents with 2 CF 709 (28.45) Authors' conflict of interest (COI)
Incidents with 3 CF 269 (10.79)
Incidents with 4 CF 78 (3.13) The authors declare that they have no potential conflicts of interest.
Incidents with 5 CF 26 (1.04)
Incidents with 6 CF 7 (0.28)
Incidents with 7 CF 5 (0.2) Acknowledgements
Incidents with 8 CF 0
Total Incidents 2492 (100) The authors would like to acknowledge Cristina Fernández (Preven-
Types of CF registered Percentage of incidents in which this CF
tive Medicine Department, Hospital Clínico San Carlos, Madrid, Spain)
appears for carrying out the statistical analysis and Vicente Aranzana (Depart-
ment of Information Technology, Hospital Universitario de Fuenlabrada,
n (%) (%)
Madrid, Spain) for the design and maintenance of the web database.
Patient factors 1074 43.09
(26.27)
Task factors 745 29.89 Appendix A. Supplementary data
(18.22)
Staff factors 623 25 Supplementary data to this article can be found online at https://doi.
(15.24) org/10.1016/j.jcrc.2018.07.012.
Education/Training 577 23.15
factors (14.11)
Equipment factors 415 16.65 References
(10.15)
Work Environment 333 (8.14) 13.36 [1] Knaus WA. Prognosis with mechanical ventilation: the influence of disease, severity
factors of disease, age, and chronic health status on survival from an acute illness. Am Rev
Team factors 165 (4.03) 6.62 Respir Dis 1989;140:S8–13.
Communication factors 156 (3.81) 6.26 [2] Esteban A, Alía I, Ibáñez J, Benito S, Tobin MJ, The Spanish Lung Failure Collaborative
Group. Modes of mechanical ventilation and weaning. A national survey of Spanish
Total CF 4088 (100)
hospitals. Chest 1994;106:1188–93.
244 Á. Alonso-Ovies et al. / Journal of Critical Care 47 (2018) 238–244
[3] Esteban A, Anzueto A, Alía I, Gordo F, Apezteguía C, Pálizas F, The Mechanical
Ventilation International Study Group. How is mechanical ventilation employed in
the Intensive Care Unit? An international utilization review. Am J Respir Crit Care
Med 2000;161:1450–8.
[4] Frutos F, Alia I, Lorenzo MR, García Pardo J, Nolla M, Ibáñez J, et al. Utilization of me-
chanical ventilation in 72 Spanish intensive care units. Med Intensiva 2003;27:1–12.
[5] Wunsch H, Angus DC, Harrison DA, Linde-Zwirble WT, Rowan KM. Comparison of
medical admissions to intensive care units in the United States and United
Kingdom. Am J Respir Crit Care Med 2011;183:1666–73.
[6] Mas N, Olaechea P, Palomar M, Alvarez-Lerma F, Rivas R, Nuvials X, et al, Grupo
ENVIN-UCI. Comparative analysis of patients admitted to Spanish Intensive Care
Units due to medical and surgical disease. Med Intensiva 2015;39:279–89.
[7] Russell WJ, Webb RK, Van der Walt JH, Runciman WB. The Australian Incident Mon-
itoring Study. Problems with ventilation: an analysis of 2000 incident reports.
Anaesth Intensive Care 1993;21:617–20.
[8] Domino KB, Posner KL, Caplan RA, Cheney FW. Airway injury during anesthesia: a
closed claims analysis. Anesthesiology 1999;91:1703–11.
[9] Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of
the difficult airway: a closed claims analysis. Anesthesiology 2005;103:33–9.
[10] Cook TM, Woodall N, Frerk C, Fourth National Audit Project. Major complications of
airway management in the UK: results of the Fourth National Audit Project of the
Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia.
Br J Anaesth 2011;106:617–31.
[11] Cook TM, MacDougall-Davis SR. Complications and failure of airway management.
Br J Anaesth 2012;109(Suppl. 1):i68–85.
[12] Needham DM, Thompson DA, Holzmueller CG, Dorman T, Lubomski LH, Wu AW,
et al. A system factors analysis of airway events from the Intensive Care Unit Safety
Reporting System (ICUSRS). Crit Care Med 2004;32:2227–33.
[13] Valentin A, Capuzzo M, Guidet B, Moreno RP, Dolanski L, Bauer P, et al, Research
Group on Quality Improvement of European Society of Intensive Care Medicine,
Sentinel Events Evaluation Study Investigators. Patient safety in intensive care: re-
sults from the multinational Sentinel Events Evaluation (SEE) Study. Intensive
Care Med 2006;32:1591–8.
[14] Merino P, Álvarez J, Cruz Martín M, Alonso Á, Gutiérrez I, SYREC Study Investigators.
Adverse events in Spanish intensive care units: the SYREC study. J Qual Health
Care]–>International J Qual Health Care 2012;24:105–13.
[15] Chacko J, Raju HR, Singh MK, Mishra RC. Critical incidents in a multidisciplinary in-
tensive care unit. Anaesth Intensive Care 2007;35:382–6.
[16] Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Peñuelas O, Abraira V, et al.. Evo-
lution of mortality over time in patients receiving mechanical ventilation. Am J
Respir Crit Care Med 2013;188:220–30.
[17] Esteban A, Anzueto A, Frutos F, Alía I, Brochard L, Stewart TE, et al, Mechanical
Ventilation International Study Group. Characteristics and outcomes in adult pa-
tients receiving mechanical ventilation: a 28-day international study. JAMA 2002;
287:345–55.
[18] Kapadia FN, Bajan KB, Raje KV. Airway accidents in intubated intensive care unit pa-
tients: an epidemiological study. Crit Care Med 2000;28:659–64.
[19] Thomas AN, McGrath BA. Patient safety incidents associated with airway devices in
critical care: a review of reports to the UK National Patient Safety Agency. Anaesthe-
sia 2009;64:358–65.
[20] Cook TM, Woodall N, Harper J, Benger J, Fourth National Audit Project. Major compli-
cations of airway management in the UK: results of the Fourth National Audit Pro-
ject of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2:
intensive care and emergency departments. Br J Anaesth 2001;106:632–42.
[21] Auriant I, Reignier J, Pibarot ML, Bachat S, Tenaillon A, Raphael JC. Critical incidents
related to invasive mechanical ventilation in the ICU: preliminary descriptive
study. Intensive Care Med 2002;28:452–8.
[22] Marco conceptual de la Clasificación Internacional para la Seguridad del Paciente.
http://www.who.int/patientsafety/implementation/icps/icps_full_report_es.pdf;
2009, Accessed date: 23 November 2017.
[23] Otero López MJ, Codina Jané C, Tamés Alonso MJ, Pérez Encinas M. Medication er-
rors: standarizing the terminology and taxomany Ruiz Jarabo 2000 grand results.
Farm Hosp 2003;27:137–49.
[24] Root Cause Analysis (RCA) tools: analysing to identify contributory factors and root
causes. http://www.nrls.npsa.nhs.uk/resources/?entryid45=75605; 2010, Accessed
date: 23 November 2017.
[25] Martín MC, León C, Cuñat J, del Nogal F. Intensive care services resources in Spain.
Med Intensiva 2013;37:443–51.
[26] Beckmann U, Baldwin I, Hart GK, Runciman WB. The Australian Incident Monitoring
Study in Intensive Care: AIMS-ICU. An analysis of the first year of reporting. Anaesth
Intensive Care 1996;24:320–9.
[27] MacRae MG. Closed claims studies in anesthesia: a literature review and implica-
tions for practice. AANA J 2007;75:267–75.
[28] Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthe-
sia: a closed claims analysis. Anesthesiology 1990;72:828–33.
[29] Bodí M, Olana M, Martín MC, Alceaga R, Rodríguez JC, Corral E, et al. Feasibility and
utility of the use of real time random safety audit in adult ICU patients: a multicenter
study. Intensive Care Med 2015;41:1089–98.
[30] Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, et al, LUNG
SAFE Investigators, ESICM Trials Group. Epidemiology, patterns of care, and mortal-
ity for patients with acute respiratory distress syndrome in intensive care units in 50
countries. JAMA 2016;315:788–800.
[31] Pattnaik SK, Nayak J, Choudhary S, Pati JP. Endotracheal intubation in intensive care
unit: a prospective study of clinical practice and adverse events. Intensive Care Med
Exp 2015;3(Suppl. 1):A940.
[32] Klotz R, Klaiber U, Grummich K, Probst P, Diener MK, Büchler MW, et al. Percutane-
ous versus surgical strategy for tracheostomy: protocol for a systematic review and
meta-analysis of perioperative and postoperative complications. Syst Rev 2015;4:
105.
[33] Añón JM, Araujo JB, Escuela MP, González-Higueras E, Grupo de Trabajo de
Insuficiencia Respiratoria Aguda de la SEMICYUC. Percutaneous tracheostomy in
the ventilated patient. Med Intensiva 2014;38:181–93.
[34] Durbin CG. Early complications of tracheostomy. Respir Care 2005;50:511–5.
[35] McGrath BA, Thomas AN. Patient safety incidents associated with tracheostomies oc-
curring in hospital wards: a review of reports to the UK National Patient Safety
Agency. Postgrad Med J 2010;86:522–5.
[36] Lee JM, Bae W, Lee YJ, Cho YJ. The efficacy and safety of prone positional ventilation
in acute respiratory distress syndrome: updated study-level meta-analysis of 11 ran-
domized controlled trials. Crit Care Med 2014;42:1252–62.
[37] Klompas M, Anderson D, Trick W, Babcock H, Kerlin MP, Li L, et al, CDC Prevention
Epicenters. The preventability of ventilator-associated events. The CDC Prevention
Epicenters Wake Up and Breathe Collaborative. Am J Respir Crit Care Med 2015;
191:292–301.
[38] Carron M, Freo U, BaHammam AS, Dellweg D, Guarracino F, Cosentini R, et al. Com-
plications of non-invasive ventilation techniques: a comprehensive qualitative re-
view of randomized trials. Br J Anaesth 2013;110:896–914.
[39] Martín-Delgado MC, Fernández-Maillo M, Bañeres-Amella J, Campillo-Artero C,
Cabré-Pericas L, Anglés-Coll R, et al. Consensus conference on providing information
of adverse events to patients and relatives. Rev Calid Asist 2013;28:381–9.
[40] Martín Delgado MC, Merino de Cos P, Sirgo Rodríguez G, Alvarez Rodríguez J,
Gutiérrez Cía I, Obón Azuara B, et al, Grupo SYREC. Analysis of contributing factors
associated to related patients safety incidents in Intensive Care Medicine. Med
Intensiva 2015;39:263–71.