Endotracheal Tubes and Fluid Aspiration An in Vitro Evaluation of New Cuff Technologies

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Mariyaselvam et al.

BMC Anesthesiology (2017) 17:36


DOI 10.1186/s12871-017-0328-0

RESEARCH ARTICLE Open Access

Endotracheal tubes and fluid aspiration: an


in vitro evaluation of new cuff technologies
Maryanne Z. Mariyaselvam1*, Lucy L. Marsh1, Sarah Bamford1, Ann Smith2, Matt P. Wise3 and David W. Williams1

Abstract
Background: Aspiration of subglottic secretions past the endotracheal tube (ETT) cuff is a prerequisite for
developing ventilator-associated pneumonia (VAP). Subglottic secretion drainage (SSD) ETTs reduce aspiration of
subglottic secretions and have demonstrated lower VAP rates. We compared the performance of seven SSD ETTs
against a non-SSD ETT in preventing aspiration below inflated cuffs.
Methods: ETTs were positioned vertically in 2 cm diameter cylinders. Four ml of a standard microbial suspension
was added above inflated cuffs. After 1 h, aspiration was measured and ETTs demonstrating no leakage were
subjected to rotational movement and evaluation over 24 h. Collected aspirated fluid was used to inoculate agar
media and incubated aerobically at 37 °C for 24 h. The aspiration rate, volume and number of microorganisms that
leaked past the cuff was measured. Experiments were repeated (×10) for each type of ETT, with new ETTs used for
each repeat. Best performing ETTs were then tested in five different cylinder diameters (1.6, 1.8, 2.0, 2.2 and 2.4 cm).
Experiments were repeated as above using sterile water. Volume and time taken for aspiration past the cuff was
measured. Experiments were repeated (×10) for each type of ETT. Results were analysed using non-parametric tests
for repeated measures.
Results: The PneuX ETT prevented aspiration past the cuff in all experiments. All other ETTs allowed aspiration, with
considerable variability in performance. The PneuX ETT was statistically superior in reducing aspiration compared to
the SealGuard (p < 0.009), KimVent (p < 0.002), TaperGuard (p < 0.004), Lanz (p < 0.001), ISIS (p < 0.001), SACETT (p < 0.
001) and Soft Seal (p < 0.001) ETTs. Of the 4 ETTs tested in differing cylinder sizes, the PneuX significantly reduced
aspiration across the range of diameters compared to the SealGuard (p < 0.0001), TaperGuard (p < 0.0001) and
KimVent (p < 0.0001) ETTs.
Conclusions: ETTs showed substantial variation in fluid aspiration, relating to cuff material and design. Variability in
performance was likely due to the random manner in which involutional folds form in the inflated ETT cuff. The
PneuX ETT was the only ETT able to consistently prevent aspiration past the cuff in all experiments.
Keywords: Ventilator-associated pneumonia, Nosocomial pneumonia, Endotracheal tube cuff, Endotracheal tube,
Pulmonary aspiration

Background (ETT) cuff, the extent of which is dependent on the


In the Intensive Care Unit (ICU), ventilator associated ETT design [2, 3].
pneumonia (VAP) is the commonest infective nosoco- The inflated ETT cuff seals the airway, allowing venti-
mial cause of mortality. In addition to the reports of lation to only occur though the tube lumen, and
mortality directly attributable to VAP, VAP increases the prevents movement of air and fluid around the ETT [4].
duration of mechanical ventilation, length of stay and However, the ETT subverts the patient’s normal pulmon-
cost [1]. A prerequisite for developing VAP is aspiration ary defence mechanisms, including mucociliary clear-
of subglottic secretions past the endotracheal tube ance and the cough reflex [2, 5]. After intubation, the
ETT, oropharyngeal surfaces and secretions rapidly be-
* Correspondence: [email protected] come colonised with pathogenic bacteria [2, 6]. Gastric
1
Oral and Biomedical Sciences, School of Dentistry, Cardiff University, Heath
Park, Cardiff, Wales CF14 4XY, UK contents reflux into the oropharynx, mix with these
Full list of author information is available at the end of the article

© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Mariyaselvam et al. BMC Anesthesiology (2017) 17:36 Page 2 of 9

secretions [7] and accumulate above the cuff. If the human tracheas. Tracheas are tapered and exhibit di-
airway seal is compromised, aspiration of these secre- mensional variability. The anterior-posterior (AP) tra-
tions occurs [4]. High bacterial load, with chemical and cheal diameter ranges between 1.27-2.38 cm for women
enzymatic injury from gastric secretions, [3] can over- and 1.68-2.86 cm for men [28]. Selecting the correct size
whelm pulmonary defences leading to microbial colon- ETT for patients is subjective and determined on the pa-
isation of the lower respiratory tract and VAP. One tient’s sex, height or weight [29]. The wrong size can
study showed that the bacteria in subglottic secretions cause tracheal ischemia (if too large) or facilitate aspir-
were identical to the causative agents of VAP in 70% of ation (if too small) [29]. A recent study identified an in-
patients [8]. Therefore, correctly achieving and main- verse relationship between tracheal size and body mass
taining the airway seal is critical in preventing VAP. index [30], highlighting potential difficulties in making
Conventionally, ETTs have high-volume, low-pressure accurate assessments. Therefore, ETTs need to account
(HVLP) cuffs [9]. The fully inflated HVLP ETT cuff for anatomical variation and safeguard the trachea.
diameter is larger than the adult trachea [10], and this This in vitro study aimed to compare ‘new generation’
design prevents tracheal mucosal injury by allowing the ETTs in the prevention of aspiration of fluids past the cuff
pressure within the cuff to be equal to the tracheal wall in ‘tracheal’ models. Experiments used microbial suspen-
pressure. Therefore, the cuff is only partially inflated, sions to highlight passage of microorganisms past the cuff,
even when correct pressures are used. The excess mater- and a physiological range of model ‘tracheas’ to determine
ial folds and causes involutions, causing channels to de- whether size affected the degree of microaspiration.
velop (Fig. 1) [9]. These channels facilitate aspiration of
subglottic secretions into the lungs. It is widely accepted
Methods
that aspiration occurs for all HVLP ETTs to varying de-
Aspiration of microbiological fluids
grees [11] and this has been consistently demonstrated
Preparation of microorganisms
in in vitro and clinical studies [10, 12–17].
Test microorganisms were Pseudomonas aeruginosa
Manufacturers have redesigned their ETTs and cuffs in
ATCC 15692, Staphylococcus aureus NCIB 9518 and
order to prevent aspiration of subglottic secretions. For
Candida albicans ATCC 90027. Bacteria and Candida
example, ETTs have been developed that allow removal
were cultured on blood or Sabouraud’s dextrose agar, re-
of subglottic fluids, thereby reducing the available vol-
spectively. Microorganisms were subcultured and grown
ume of secretions entering the lungs. These subglottic
overnight (18 h) in Tryptic Soy Broth at 37 °C. Cells
secretion drainage (SSD) ETTs, have demonstrated lower
were harvested by centrifugation, and the pellets washed
VAP rates [12, 18–24]. Other ETTs use novel cuff mate-
in phosphate buffered saline (PBS). This was repeated
rials to reduce the number or size of channels [25], vari-
(×2) and microorganisms were re-suspended in PBS to a
ations to the cuff shape, employ devices to continuously
turbidity of 0.1 OD. One ml of each bacterial and can-
maintain cuff pressure [26] or employ antibacterial coat-
dida suspension was combined and added to 1 ml of
ings [27]. However, in ETT design, manufacturers must
PBS to produce a 4 ml inoculum. On each experimental
account for the variability in the size and shape of
day, a starting concentration equating to 0.1 OD was
used. To minimise variation in the number of viable
cells between experiments on different occasions, the
same number of colonies were inoculated into Tryptic
Soy Broth and incubated for the same period of time
(18 h) before preparation and adjustment in PBS.

ETT model
A ‘model trachea’ was developed (Fig. 2a) by aseptically
connecting the tip of a 20 ml syringe barrel (Becton
Dickinson Plastipak, County Louth, Ireland) to a 10 ml
enteral syringe (barrel and plunger) (Enteral UK,
Yorkshire, UK). The 20 ml syringe barrel, representing
Fig. 1 A high-volume-low-pressure cuff inflated to 30 cmH20 inside a
2.0 cm ‘trachea’. The blue dye is placed above the inflated cuff to the trachea had a 2 cm internal diameter into which the
demonstrate aspiration of fluid past the cuff. Despite inflating the ETT ETT was placed and the enteral syringe was used to
cuff to the correct tracheal wall pressure, it is only partially inflated with capture the aspirated secretions. Seven ETTs (8.0 mm)
excess material folding and causing involutions. The blue dye with design variations to prevent leakage of subglottic
highlights the formation of channels, which allow leakage of subglottic
secretions and a standard non-SSD ETT (8.0 mm) were
fluid into the lungs overhead view (a) and a lateral view (b)
selected for testing (Table 1).
Mariyaselvam et al. BMC Anesthesiology (2017) 17:36 Page 3 of 9

test (140° axial rotation, to mimic oral care movements)


was applied to the proximal end of the ETT after the ini-
tial 1 h period at 0, 15, 30 and 45 min. If no leak was
evident after the movement tests, the enteral syringe was
disconnected from the tip of the 20 ml syringe barrel,
aseptically filled with 4 ml of sterile PBS and re-con-
nected to the tip of the 20 ml syringe barrel. The 4 ml
sterile PBS was then injected into the 20 ml syringe below
the inflated ETT cuff. The PBS was withdrawn and the
fluid processed to determine potential ‘micro leaks’.
The collected microbial fluid was serially decimal di-
luted in PBS. Fifty μl of the diluted suspensions were
plated on to Tryptone Soya Agar and incubated aerobic-
ally at 37 °C for 24 h. The resulting number of colony
forming units (cfu) were then counted. Experiments
were repeated (×10) for each ETT type and new ETTs
were used for each repeat.
ETTs that did not leak during any of the static or
movement tests were subjected to a 24 h static test. Ex-
periments were repeated (×3), with new ETTs used for
each repeat.

Effect of ‘tracheal size’ on aspiration


The 4 ‘best performing’ ETTs from the microbiological
study were analysed in these experiments. Model
tracheas were developed using rigid glass cylinders, with
internal diameters of 1.6, 1.8, 2.2 and 2.4 cm (Dabble
Labs UK, Kent UK) (Fig. 2b). For the 2.0 cm sized ‘tra-
chea’ diameter, the syringe model described above (and
shown in Fig. 2a) was utilised. ETTs were positioned ver-
Fig. 2 a The in vitro trachea model used in the aspiration of microbial tically and the study was conducted as outlined above.
fluid study. The 20 ml syringe was connected to the 10 ml enteral However, in these studies, 4 ml of sterile water (B. Braun
syringe via the tip. The endotracheal tube was placed in the 20 ml
syringe. Fluid leaking past the cuff was collected aseptically in the enteral
Melsungen AG, Melsungen, Germany) was added above
syringe. b the in vitro trachea model used in the range of tracheas study. the ETT cuff. The volume and time taken for leakage
The endotracheal tube was placed inside the rigid glass ‘trachea’ and the past the cuff was measured. Experiments were con-
fluid leaked past the cuff was collected inside the model ducted over a 1 h period. If no aspiration was observed,
a standard movement test was applied to the proximal
ETT as previously described. Experiments were repeated
Assessment of aspiration (×10) for each tracheal size.
Experiments were conducted at 37 °C in a temperature
and humidity controlled environment. The distal cuffed Statistic analysis
ETT was aseptically placed inside the 20 ml syringe bar- Statistical analysis was performed using the R Project
rel and the cuff inflated to the correct pressure using a Model for statistical analysis (The R Foundation, 2014).
hand-held manometer (Portex, Smiths Medical Inter-
national Ltd, Kent, UK) according to the manufacturer’s Aspiration of microbiological fluids
instructions. If continuous cuff pressure monitors were Results were analysed using ANOVA analysis and a
recommended, these were used to maintain cuff inflation Tukey multiple comparison of the means. This test
during experiments. compared the overall performance of all ETTs in pre-
Four ml of standardised microbial suspension was venting aspiration of microbial fluids past the cuff
added above the ETT cuff. The time taken for the fluid and compared the volume (ml/min) and quantity of
to leak past the ETT cuff was measured. Any fluid that cfu that leaked past the cuff over time (cfu/min). Fur-
leaked past the cuff within 1 h, was collected in the en- ther analysis was performed using non-parametric
teral syringe and this was recorded as a tube leak. In statistical tests for repeated measures using a pairwise
cases of no observed fluid leak, a standard movement Mann–Whitney U Test.
Mariyaselvam et al. BMC Anesthesiology (2017) 17:36 Page 4 of 9

Table 1 Properties of the ETTs used in the study and the novel technologies used to prevent aspiration of subglottic secretions
ETT and cuff Portex, Smiths Venner, Jo Koon Mallinckrodt, Covidien Massachusetts, USA Kimberly-Clark, Teleflex UK,
pressure monitor Medical, Kent, UK Circle, Singapore Georgia, USA Athione,
Manufacter Ireland
ETT Portex Soft Seal Portex SACETT™ Venner™ PneuX Mallinckrodt™ Mallinckrodt™ Mallinckrodt™ Hi-Lo KimVent™ MICROCUFF™ Teleflex ISIS®
® Cuff Tracheal Suction Above P.Y.™ ETT SealGuard™ TaperGuard™ Oral Endotracheal Subglottic Suctioning HVT™
Tube ET Cuff Evac Endotracheal Tube Evac Oral Tube, Lanz System Endotracheal Tube
Endotracheal Tube
Cuff type HVLP HVLP LVLP HVLP HVLP HVLP HVLP HVLP
Cuff material PVC PVC Silicone Poly-urethane PVC PVC Poly-urethane PVC
Cuff shape Cylindrical Tapered Cylindrical Tapered Tapered Cylindrical Cylindrical elongated Tapered
Cuff resting 3 3 Dependent on 2.7 2.54 3.3 3 2.8
diameter (cm) tracheal size
Recommended 30 30 80 (=30) 20-30 20-30 25-33 20-30 20-30
Cuff Pressure
(cm H20)
Subglottic port(s) 0 1 3 1 1 0 1 1, detachable
Cuff pressure No Pressure Easy Tracheal Seal No No Lanz valve inflated No No
monitor Monitor to 30-34 cm H2O

Effect of ‘tracheal size’ on aspiration ETT, all ETTs demonstrated leakage of microorganisms
Results were analysed using non-parametric statistical ana- past the cuff. The Portex Soft Seal, Lanz, ISIS and
lysis for repeated measures and stratifying by size of the SACETT ETTs leaked 4 ml of microbial fluid on all occa-
glass trachea using the Wilcoxon-Nemenyi-McDonald- sions (between <5 min and 1 h). The SealGuard, KimVent
Thompson test [31], comparing the ETTs and the fluid and TaperGuard ETTs leaked on some occasions and these
volume leaked past the cuff (ml/min). were analysed in the movement test. Once rotation was
applied, aspiration of bacterial fluid occurred with all
Results TaperGuard and KimVent ETTs and on some occasions
Aspiration of microbiological fluids with the SealGuard ETT. The PneuX ETT was the only
Aspiration was expressed as total cfu/min and volume of ETT that progressed to the 24 h test. There was no macro
fluid leaked past the cuff. With the exception of the PneuX or microaspiration of microorganisms past the cuff with

Fig. 3 Aspiration of microbial fluid study. ETTs used in the study are shown on the x-axis and include the results of the 24 h study. a Log of
colony forming units aspirated past the cuff for each ETT. b Volume of fluid leaked past the ETT on a logarithmic scale. Results demonstrate that
the PneuX ETT was the only tube that prevented aspiration of bacteria in the static, movement and 24 h study. Variability of the results occurred
between repeats of the HVLP ETTs
Mariyaselvam et al. BMC Anesthesiology (2017) 17:36 Page 5 of 9

the PneuX ETT in the stationary, movement or 24 h non-parametric statistical analysis for repeated measures
experiments (Fig. 3). was again used to compare all other ETT results against
ANOVA analysis demonstrated a significant difference the PneuX ETT. The PneuX ETT was found to signifi-
between all of the studied ETTs when comparing micro- cantly reduce fluid aspiration compared with the Seal-
bial fluid leakage (p < 0.00001). The PneuX ETT did not Guard (p < 0.0001), TaperGuard (p < 0.0001) and KimVent
allow aspiration in any experiment and therefore, non- (p < 0.0001) ETTs.
parametric statistical analysis for repeated measures was
used to compare all other ETT results against the PneuX Discussion
ETT. The PneuX ETT demonstrated significantly re- Aspiration of pathogenic subglottic secretions past the
duced aspiration compared to the SealGuard (p < 0.009), ETT cuff is a recognised risk factor for VAP [9]. All
KimVent (p < 0.002), TaperGuard (p < 0.004), Lanz (p < HVLP ETT cuffs form channels allowing aspiration of
0.001), ISIS (p < 0.001), SACETT (p < 0.001) and Soft subglottic secretions [11]. Manufacturers have rede-
Seal (p < 0.001) ETTs. signed aspects of their ETTs to limit this. These studies
compared 8 ETTs in preventing aspiration past the cuff
Correlation in terms of microorganisms and fluid volume. Selected
A liner correlation between volume and cfu/min leaking ETTs required a novel design incorporated to prevent
past the cuff was demonstrated, correlation co-efficient subglottic fluid aspiration, with the exception of the
0.826, p < 0.0001 (Fig. 4). This high correlation allowed Portex Soft Seal, which is one of the commonest ETT in
volume of fluid to be used as a surrogate for bacterial clinical use in the UK.
load in the effect of ‘tracheal size’ on aspiration In this study, all HVLP ETT cuffs exhibited leakage of
experiments. microbial fluids past the cuff. Only the PneuX ETT (low
volume, low pressure (LVLP) cuff ), consistently pre-
Effect of ‘tracheal size’ on aspiration vented aspiration of fluid under all test conditions (Fig. 3
The 4 ETTs (PneuX, SealGuard, KimVent and Taper- and 5, 6). Aspiration of microorganisms occurred in all
Guard ETTs) subjected to the movement test in the experiments with the Lanz, ISIS, SACETT and Soft Seal
microbiological study were selected for testing using dif- ETTs. Results were variable in terms of leaked volume,
ferent sized ‘trachea models’. Aspiration was expressed rate of leakage and microbial aspiration. With the
as volume of fluid leaked past the cuff. SealGuard, TaperGuard and the KimVent ETTs, some
With the exception of the PneuX ETT, all ETTs dem- tubes permitted aspiration almost immediately, some
onstrated leakage of fluid past the cuff across the differ- progressed to the movement study and some did not
ent trachea sizes. Of the trachea sizes tested, the ‘best’ leak after manipulation. Similar results were seen for the
diameters for the SealGuard and TaperGuard ETTs were ‘trachea size’ study, where performance was also variable.
the 2.0 and 2.2 cm, and for the KimVent ETT it was The variation within the same type of ETTs, likely re-
2.4 cm (Fig. 5). Since the PneuX ETT demonstrated no lates to the manner in which folds develop within the
aspiration of fluid past the cuff for any tracheal size cuff during inflation, which appears to be random

Fig. 4 Correlation between volume leaked past the cuff and number of CFU count. Correlation co-efficient = 0.826, p < 0.0001
Mariyaselvam et al. BMC Anesthesiology (2017) 17:36 Page 6 of 9

Fig. 5 Effect of tracheal size (1.6, 1.8, 2.0, 2.2 and 2.4 cm) on aspiration (volume of fluid) past the cuff per hour. The PneuX ETT was the only tube
that prevented the aspiration of fluid at each tracheal size. Variability of the results was evident for each HVLP ETT

(Fig. 6). This was highlighted in the movement study, results in clinical practice. A recent clinical study re-
where upon manipulation, the folds in the cuffs that had ported that the KimVent, TaperGuard and SealGuard
originally formed in such a way to prevent leakage in the ETTs were not superior to a standard ETT in preventing
static model moved, enabling a fluid pathway to develop tracheal colonisation or VAP [17]. Indeed, our results in
thus allowing leakage of fluid. The variability in perform- this in vitro model would have predicted that in a clin-
ance evident in these studies could lead to unpredictable ical trial [17], where expected duration of ventilation

Fig. 6 Aspiration of fluid (blue dye) past the cuff and differences in channel formation seen with each ETT cuff. (a) Portex Soft Seal ® Cuff Tracheal
Tube, (b) The Venner™ PneuX P.Y. ™ ETT (c) Mallinckrodt™ SealGuard™ Evac Endotracheal Tube, (d) KimVent™ MICROCUFF Subglottic Suctioning
Endotracheal Tube, (e) MallinckrodtTM Tapergurad™ Evac Oral Endotracheal Tube, (f) Mallinckrodt™ Hi-Lo Oral Endotracheal Tube, Mallinckrodt™
Lanz System, (g) Teleflex ISIS® HVT™ and (h) SACETT™ Suction Above ET Cuff
Mariyaselvam et al. BMC Anesthesiology (2017) 17:36 Page 7 of 9

was greater than 48 h the KimVent, TaperGuard and simulate the presence of pathogenic organisms com-
SealGuard ETTs would have not have performed better monly found in the subglottic space. The species used
than a standard ETT in preventing VAP. were frequent causative agents of VAP [6, 8]. Clinically
Certain HVLP cuff designs are reported to reduce the microbial counts of 1 × 104 cfu/ml from bronchoalveolar
rate of aspiration and prevent VAP [10, 12–16]. Ultra-thin lavages are indicative of VAP [38]. In this study, the mi-
polyurethane cuffs (wall thickness 7–10 μm) develop finer crobial solution was equivalent to ca. 107 cells/ml. Al-
folds; thereby reduce the rate of aspiration, but not pre- though higher than typically encountered clinically,
vent it [13, 32] and this was evident in this study with the this served to enhance discrimination and sensitivity
KimVent and SealGuard ETTs, which leaked slowest and of the experiments. In experiments where no visible
lowest volumes. Tapered cuffs have reportedly shown aspiration was seen, the space below the cuff was irri-
benefit over cylindrical cuffs [14, 33]. In this study the gated to determine whether micro-leaks occurred and
TaperGuard and SealGuard ETTs performed better than in this study, no microaspiration of microorganisms
most HVLP ETTs. However, both the tapered ISIS and were detected.
SACETT ETT cuffs made of polyvinylchloride, permitted In initial experiments, the correlation between cfu/min
aspiration on all occasions. Polyvinylchloride cuffs (wall and volume leaked past the cuff was demonstrated and
thickness 50 μm) [9] develop larger folds which allow volume of fluid was therefore used as a surrogate for
greater aspiration of subglottic secretions. This may indi- bacterial load in the ‘trachea size’ study. It was important
cate that cuff material is of greater importance than cuff to test ETTs across a range of trachea sizes, due to the
shape in terms of preventing leakage [32]. The combin- considerable anatomical variability [28]. One may argue
ation, seen in the SealGuard ETT, appears to afford that clinicians would not use a size 8.0 ETT in patients
greater protection, as this was the best performing HVLP with 1.6 or 2.4 cm tracheas. However, patients are not
ETT in this study. routinely scanned to assess tracheal size prior to intub-
Studies show that maintaining cuff pressure correctly ation and studies have shown the inaccuracies in clini-
reduces the incidence of VAP [34]. In this study the cians assessing tracheal size [30]. Using a size 8.0 ETT
Lanz and SACETT ETTs were used with their recom- in this range of trachea sizes, represents rigorous bench
mended cuff pressure monitors, however their perform- testing and better comparison to clinical practice and
ance was not superior to the Soft Seal ETT. Maintaining anatomical variation.
correct cuff pressure is important however this study Many clinical trials with novel ETTs aimed at preventing
showed that the properties of the ETT cuff may be VAP often show disappointing results. These are costly,
equally important in preventing aspiration. time consuming and often fail to replicate in vitro results
The PneuX ETT consistently prevented aspiration in [39]. Our study tested 8 ETTs across a range of ‘trachea’
all experiments. The LVLP cuff of the PneuX ETT is sizes, included movement tests and extended durations to
made of highly elastic silicone and uniformly inflates increase robustness. ETTs that appear to prevent aspir-
until the correct tracheal wall pressure is achieved at the ation in bench tests should be subjected to pilot in-patient
required tracheal circumference, hence, the cuff does studies, where primary outcome measures of aspiration
not develop folds (Fig. 6) [35]. The PneuX ETT used a are biomarkers such as pepsin, amylase and bacterial
tracheal seal monitor, designed to maintain the pressure counts [40, 41]. This would demonstrate the adequacy of
of the silicone cuff at the appropriate pressure at all an ETT to prevent aspiration and would also allow larger
times, even during movement [35] and this was demon- clinical trials to be adequately powered.
strated in this study. Our results replicate previous in
vitro studies which demonstrate no leakage past the cuff Conclusions
for the PneuX ETT and superior performance when Prevention of aspiration past the ETT cuff is a prerequis-
compared to other ETT examined [10, 36]. Our findings ite for averting VAP. In these investigations, variation in
are also supported by a recent publication by Chenelle the efficacy of HVLP ETTs was apparent and likely due
et al., which demonstrated leakage in a different bench to the random manner in which folds develop in the
model [37]. In their study, Chenelle et al., showed leak- cuff. The PneuX ETT was the only ETT to consistently
age occurred with all HVLP cuffs tested and was pre- prevent aspiration past the cuff in all experiments. The
vented by the PneuX cuff [37]. Our study confirms and PneuX ETT should be further evaluated in patients using
builds on this data, by testing all the SSD ETT currently biomarkers of aspiration to determine whether these
available and also examines the quantification of the results are replicated clinically.
bacterial load which the lungs may be exposed to. Com-
monly, in vitro studies have used water to demonstrate Abbreviations
AP: Anterior-posterior; ETT: Endotracheal tube; HVLP: High-volume, low-
leakage past the cuff [10, 12, 32, 37]. Our study is novel pressure; PBS: Phosphate buffered saline; SSD: Subglottic secretion drainage;
in its use of a microbial solution, which was used to VAP: Ventilator associated pneumonia
Mariyaselvam et al. BMC Anesthesiology (2017) 17:36 Page 8 of 9

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Availability of data and materials endotracheal tube cuff using an in-vitro model. HSR Proc Intensive Care
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Authors’ contributions secretions, an in-vitro study. Eur J Anaesthesiol. 2014;31:166–71.
MZM, MPW and DWW conceived the study. MZM, LLM and SB undertook 16. Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, et al.
data collection. AS and MZM conducted statistical analysis of the data. MZM, Effect of positive expiratory pressure and type of tracheal cuff on the
MPW and DWW contributed to the drafting and revising of the manuscript. incidence of aspiration in mechanically ventilated patients in an intensive
All authors read and approved the final version of the manuscript. care unit. Crit Care Med. 2008;36:409–13.
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Competing interests intubation with polyurethane or conical cuffs to prevent pneumonia in
MPW has been on an advisory board for Kalobius Pharmaceuticals. He has ventilated patients. Am J Respir Crit Care Med. 2015;191:637–45.
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aspiration of subglottic secretions in cardiac surgery patients. Chest. 1999;
Consent for publication 116:1339–46.
Not applicable. 20. Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A,
Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S.
Ethics approval and consent to participate Intermittent subglottic secretion drainage and ventilator-associated
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Author details randomized clinical trial of intermittent subglottic secretion drainage in
1
Oral and Biomedical Sciences, School of Dentistry, Cardiff University, Heath patients receiving mechanical ventilation. Chest. 2002;121:858–62.
Park, Cardiff, Wales CF14 4XY, UK. 2School of Biosciences, Cardiff University, 22. Damas P, Frippiat F, Ancion A, Canivet JL, Lambermont B, Layios N, Massion
Cardiff, Wales, UK. 3Adult Critical Care, University Hospital of Wales, Cardiff, P, Morimont P, Nys M, Piret S, Lancellotti P, Wiesen P, D'orio V, Samalea N,
Wales, UK. Ledoux D. Prevention of ventilator-associated pneumonia and ventilator-
associated conditions: a randomized controlled trial with subglottic
Received: 8 December 2016 Accepted: 20 February 2017 secretion suctioning. Crit Care Med. 2015;43:22–30.
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