BRIEF COMMUNICATION

Use of the Blom Tracheotomy Tube with Suction Inner Cannula to

Decontaminate Microorganisms from the Subglottic Space
A Proof of Concept
Lesley Rabach1, Mark D. Siegel2, Jonathan T. Puchalski3, Dana Towle4, Michelle Follert5, Kelsey M. Johnson6,
Alfred W. Rademaker7, and Steven B. Leder1
1
Department of Surgery, Section of Otolaryngology, 2Department of Internal Medicine, Section of Pulmonary and Critical Care,
and 3Department of Internal Medicine, Section of Pulmonary and Critical Care, Yale School of Medicine, New Haven,
Connecticut; 4Department of Laboratory Medicine, 5Medical Intensive Care Unit, and 6Yale-New Haven Hospital, New Haven,
Connecticut; and 7The Robert H. Lurie Comprehensive Cancer Center, Biostatistics Core Facility, Department of Preventive Medicine,
Northwestern University Feinberg School of Medicine, Chicago, Illinois

Abstract versus subglottic suction samples (2.48 6 1.07) (paired t test,

Rationale: Preventing pulmonary complications during
mechanical ventilation via tracheotomy is a high priority.
Objectives: To investigate if the Blom tracheotomy tube with suction-
above-the-cuff inner cannula reduced the quantity of normal flora
and pathogens in supra- versus subglottic spaces.
Methods: We enrolled 20 consecutive medical ICU adults requiring
tracheostomy for mechanical ventilation in this proof-of-concept,
prospective, single-center study. All participants received a Blom
tracheotomy tube with suction-above-the-cuff inner cannula to
decontaminate microorganisms from the supra- and subglottic
spaces. Supra- and subglottic sputum samples were obtained for
microbiologic analysis while an endotracheal tube was in place before
tracheotomy and once per week for up to 4 weeks of mechanical
ventilation after tracheotomy.
Measurements and Main Results: Demographics, duration
of endotracheal tube intubation, and duration of mechanical
ventilation post-tracheotomy were recorded. There was a
significant reduction for supraglottic (2.86 6 1.11 [mean 6 SD])
P = 0.048; Wilcoxon test, P = 0.045) when all data pairs for normal
flora and pathogens were combined across times. There was
a significant reduction of normal flora pooled across times in 19
data pairs for supraglottic (3.00 6 1.05) versus subglottic suction
samples (2.00 6 0.94) (paired t test, P = 0.0004; Wilcoxon test,
P = 0.0007). There was no significant reduction of pathogens
pooled across times in 25 data pairs for supraglottic (2.76 6 1.16)
versus subglottic suction samples (2.84 6 1.03) (paired t test,
P = 0.75; Wilcoxon test, P = 0.83).
Conclusions: Proof-of-concept was confirmed. The Blom
tracheotomy tube with disposable suction-above-the-cuff inner
cannula decontaminated microorganisms from the subglottic
space when normal flora and pathogens were combined. Future
research should investigate if decreased quantity of normal flora
and pathogens in the subglottic space reduces the incidence of
ventilator-associated pulmonary complications in critically
ill patients requiring ongoing mechanical ventilation via
tracheotomy.
Keywords: mechanical ventilation; tracheotomy; intensive
care unit; ventilator-associated pneumonia

(Received in original form January 8, 2015; accepted in final form April 3, 2015 )
Supported by the Department of Surgery, Section of Otolaryngology, Yale School of Medicine.
Author Contributions: L.R. was involved in the conception, hypothesis delineation, design, acquisition of data, data analysis, interpretation of results, writing,
and final approval. M.D.S. was involved in the conception, hypothesis delineation, design, interpretation of results, writing, and final approval. J.T.P. was
involved in the data analysis, interpretation of results, writing, and final approval. D.T. was involved in the design, acquisition of data, interpretation of results,
writing, and final approval. M.F. was involved in the acquisition of data, writing, and final approval. K.M.J was involved in the acquisition of data, writing, and
final approval. A.W.R was involved in the data analysis, interpretation of results, writing, and final approval. S.B.L. was involved in the conception, hypothesis
delineation, design, acquisition of data, data analysis, interpretation of results, and writing.
Correspondence and requests for reprints should be addressed to Steven B. Leder, Ph.D., CCC-SLP, Yale School of Medicine, Dept. of Surgery, Section of
Otolaryngology, P.O. Box 208041, New Haven, CT 06520-8041. E-mail: steven.leder@yale.edu
Ann Am Thorac Soc Vol 12, No 6, pp 859–863, Jun 2015
Copyright © 2015 by the American Thoracic Society
DOI: 10.1513/AnnalsATS.201501-010BC
Internet address: www.atsjournals.org

Rabach, Siegel, Puchalski, et al.: Tracheotomy Tube to Decontaminate Subglottic Space 859

The inflated cuff of a tracheotomy or
endotracheal tube does not provide
a circumferential water-tight seal against the
tracheal mucosa. Leakage of supra- and
subglottic pooled secretions around the
cuff will inevitably contaminate the lower
respiratory tract (1). Removal of these
above-the-cuff secretions and the inherent
microorganisms has the potential to reduce
the incidence of ventilator-associated
pneumonia and related pulmonary
complications (2). Two systematic reviews
and metaanalyses investigated subglottic
secretion drainage issues and found that
endotracheal tubes with subglottic suction
capability reduced the incidence of
ventilator-associated pneumonia (2, 3).
Transition from an endotracheal
tube to a tracheotomy tube has several
advantages when long-term mechanical
ventilation is required, including improved
patient comfort, maintenance of oral
hygiene, and reduced risk of laryngeal
injury. However, there is a paucity of data
on the ability of suction-above-the-cuff
tracheotomy tubes to reduce aspiration
volume below the cuff, and there is no
information on the microbiology associated
with the aspirate. Two prior studies used
a tracheotomy tube with the suction line
located on the exterior surface of the
tracheotomy tube and thereby unrelated to
the inner cannula (4, 5). The in vivo model
(4) found a reduction in below-the-cuff
transit of a saliva bolus, and the in vitro
model (5) reported a decreased incidence
of ventilator-associated pneumonia.
Although feasible, having the suction
line on the exterior surface of the
tracheotomy tube is not optimal (6) because
(1) it is not associated with the inner cannula
and thus may not keep the inner cannula
decontaminated, (2) removal requires
replacement of the entire tracheotomy
tube, and (3) there is potential for mucosal
erosion and granulation tissue formation.
Table 1. Participant demographics
Male/female Mean Length of
Age (yr) Hospital Stay (d)
9/11 52.3 45.9 (20.3)†
(range, 22–71)
Definition of abbreviations: ETT = endotracheal tube; ICU = intensive care unit.
*Two participants died at post-tracheotomy tube Days 1 and 2 and were eliminated from analysis.
†
Values are mean (SD) unless otherwise noted.
860
We evaluated the Blom Tracheostomy
Tube System (Pulmodyne Corp.,
Indianapolis, IN) with the unique subglottic
suctioning inner cannula. This novel
tracheotomy tube was designed with the
suction line interior to the tube, thereby
making the suction line integral to the
disposable suction inner cannula. The
purpose of this proof-of-concept
investigation was to determine if the
Blom tracheotomy tube with suction-
above-the-cuff inner cannula reduced the
quantity of microorganisms (i.e., normal
flora and pathogen counts) in suction
samples from the supra- versus subglottic
spaces.
Methods
Subjects
This study was approved by the Institutional
Review Board and Human Investigation
Committee, Yale School of Medicine, which
approved conduct of this research without
explicit consent from participants. A
consecutively referred sample (November
23, 2011 to February 10, 2012) of 20 adults
from the Medical and Neurosurgical
intensive care units (ICUs) of a large, urban,
tertiary care, teaching hospital participated.
The ICU providers, who were not members
of the research team, determined the need
for tracheotomy placement. Inclusion
criteria were >18 years of age, expectation
of .72 hours of mechanical ventilation via
endotracheal tube (ETT), no preexisting
infectious pulmonary disease, and
placement of the Blom tracheotomy
tube with suction-above-the-cuff inner
cannula. Exclusion criteria were previous
tracheotomy; anatomical or surgical
reasons precluding a tracheotomy tube;
or a current diagnosis of pneumonia,
chronic purulent bronchitis, or
bronchiectasis. Participant demographics,
Length of Duration of
ICU Stay (d) ETT (d)
32.5 (17.1) 15.8 (6.1)
AnnalsATS Volume 12 Number 6 | June 2015
BRIEF COMMUNICATION
duration of ETT intubation, and duration
of mechanical ventilation via tracheotomy
tube were recorded (Table 1).
Device Description
The Blom tracheotomy tube was designed
for decontamination of microorganisms
from the subglottic space in patients
requiring mechanical ventilation and
a fully inflated cuff. This is accomplished by
a uniquely designed tracheotomy tube
with a disposable suction inner cannula
allowing for the capability to suction the
subglottic space (i.e., the space between the
true vocal folds superiorly and the inflated
cuff inferiorly). The suction line is integral
to the disposable inner cannula with the
distal end connected to a fenestration
located just superior to the inflated cuff,
thus allowing exit through the outer
cannula (Figure 1).
Procedures
A tracheotomy was performed by
interventional pulmonary physicians using
the percutaneous dilatational technique or
by members of the surgical staff using the
open technique. The Blom tracheotomy
tube was either a size 6.0 or 8.0 and once
placed was not changed. After Blom
tracheotomy tube placement, the inner
cannula suction channel was attached to
wall suction set continuously at 10 mm Hg.
Sterile tubing was used, and the canister
and tubing were changed daily by
the ICU nursing staff. Standard ICU
prophylaxis for prevention of pneumonia
included head-of-bed elevation to 30 to
45 degrees and application of chlorhexidine
mouth rinses twice daily.
Supra- and subglottic sputum samples
were collected on the day of tracheotomy
with the ETT in place and after tracheotomy
at weekly intervals for up to 4 weeks of
mechanical ventilation. A new suction inner
cannula was placed before a sterile suction
Duration of Time from
Tracheotomy* (d) Tracheotomy
to Discharge (d)
12.3 (9.5) 27.0 (10.8)
 BRIEF COMMUNICATION
Figure 1. The Blom tracheotomy system includes the tracheotomy tube with fenestrations above
the cuff and a disposable inner cannula with suction line on its outer surface terminating at the lower
portion of the fenestrations directly above the cuff.
catheter collected each sputum sample. The
first sputum sample was obtained from the
subglottic area using the Blom suction-
above-the-cuff inner cannula (Figure 2).
Figure 2. Supra- and subglottic sputum sample collection areas (marked by 1).
Rabach, Siegel, Puchalski, et al.: Tracheotomy Tube to Decontaminate Subglottic Space
The second sputum sample was obtained
using a sterile suction catheter applied to
the posterior oropharynx (Figure 2). If
a patient was weaning off the ventilator
before the scheduled weekly interval, one
final supra- and subglottic sample was
collected.
The samples were collected with
a specimen trap (Cat. no. 8884724500;
McKesson Medical-Surgical, Inc.,
Northborough, MA) and immediately
hand-carried to microbiology for plating
and analysis to determine type and quantity
of microorganisms. Semiquantitative
colony counts by plate quadrant
(i.e., 11, 21, 31, and 41) were performed
according to standard microbiologic
methods (7). They rank from 1 (low
colony counts) to 4 (high colony counts).
Cultures were characterized as normal flora
or pathogens based on the identification
of organisms known to cause respiratory
infections (e.g., Streptococcus pyogenes,
Staphylococcus aureus, and Pseudomonas
aeruginosa). Microbiology laboratory
technologists were blinded to the purpose
of the study.
Decontamination was defined as a
reduction in the quantity of microorganisms
in the subglottic space versus the
supraglottic space. Supra- versus subglottic
suction samples were compared only if
growth was quantifiable (7), resulting in
a combined analysis of 44 pairs and
separate analyses of 19 normal flora and
25 pathogen pairs. All comparisons
between supra- and subglottic areas were
made using the paired t test and were
confirmed by the nonparametric
Wilcoxon signed rank test.
Results
There was a significant reduction for
supraglottic (2.86 6 1.11 [mean 6 SD])
versus subglottic suction samples (2.48 6
1.07) (paired t test, P = 0.048; Wilcoxon
test, P = 0.045) when all pairs of data for
normal flora and pathogens were combined
across times (i.e., up to 4 wk of mechanical
ventilation) (Table 2). There was a
significant reduction of normal flora
pooled across times in 19 data pairs for
supraglottic (3.00 6 1.05) versus subglottic
suction samples (2.00 6 0.94) (paired t
test, P = 0.0004; Wilcoxon test, P = 0.0007)
(Table 3). There was no significant
reduction of pathogens pooled across
times in 25 data pairs for supraglottic
(2.76 6 1.16) versus subglottic suction
samples (2.84 6 1.03) (paired t test, P =
0.75; Wilcoxon test, P = 0.83) (Table 3).
861
 BRIEF COMMUNICATION

Table 2. Separate and combined normal flora and pathogen (44 pairs) count means for significantly reduced the incidence of
supraglottic and subglottic suction samples ventilator-associated pneumonia in ICU
patients without an increase in adverse
Supraglottic Suction Subglottic Suction events (2, 3).
Samples Samples The only above-the-cuff tracheotomy
tube with suction capability used to date
Day of tracheotomy (n = 20) 2.65 (1.18)* 2.26 (0.99) has the suction line located on the exterior
First week (n = 18) 2.59 (1.06) 1.88 (1.02) surface of the tracheotomy tube (4, 5).
Second week (n = 12) 2.83 (1.19) 3.18 (0.87) The Blom tracheotomy tube, designed
Third week (n = 5) 3.20 (0.84) 2.80 (0.84) with an interior and disposable suction
Fourth week (n = 2) 3.50 (0.50) 4.0 (0.00)
Combined 2.86 (1.11)* 2.48 (1.07)† inner cannula, obviates complications
associated with using a fixed line on the
*Values in parentheses are SD. outer surface of the tracheotomy tube
†
P = 0.048. (Figure 1). For example, flushing a clogged
suction line with saline actually forces
Discussion both the in vivo model, which found normal flora and pathogens back into the
a reduction in distal transit of a saliva subglottic space. Additionally, in countries
Since 2006, the Institute for Healthcare bolus (4), and the in vitro model, which where disposable inner cannula designed
Improvement has emphasized the need indicated that use of above-the-cuff tubes are not in frequent use, the Blom
to reduce health care–associated infections suction tracheotomy tubes has the suction-above-the-cuff inner cannula
with the goal of reducing overall health care potential to decrease the risk of ventilator- can be removed, flushed, cleaned, and
costs. Prevention of ICU-related pulmonary associated pneumonia by preventing reinserted, whereas with a fixed exterior
complications in patients requiring aspirated secretions from entering the line the entire tracheotomy tube needs to
mechanical ventilation via tracheotomy is lower airways (5). The current study helps be replaced.
a high-priority area because the resultant explain the reason for the prior results The limitations of this proof-of-
savings could be in the millions of dollars by showing that decontamination of the concept study were the small sample size,
on a nationwide basis. subglottic space via above-the-cuff the use of subjects from a single institution,
In this proof-of-concept study, use suctioning reduced the quantity of and the short 4-week follow-up period.
of the Blom tracheotomy tube with microorganisms in the aspirate. The strengths of this proof-of-concept study
suction-above-the-cuff inner cannula to The present findings expand on and are its prospective design, consecutive
decontaminate the subglottic space of support the concept that suctioning participant accrual, and the blinded
microorganisms resulted in a significant subglottic secretions pooled above the cuff microbiological analysis of sputum samples.
reduction for supra- versus subglottic of either a tracheotomy tube (4, 5) or Our results support further research with
suction samples when all pairs of data for an endotracheal tube (8–13) may have a control group where patients are randomly
normal flora and pathogens were combined the beneficial effect of decreasing the assigned tracheotomy tubes with and
for up to 4 weeks of mechanical ventilation. incidence of ventilator-associated without above-the-cuff suction capability.
When analyzed separately, there was pneumonia and related pulmonary Additional research with a larger sample
a decreased quantity of normal flora but not complications. This is reinforced by two size, a multiinstitutional sample, and
pathogens in the subglottic space because systematic reviews and metaanalyses that a longer follow-up period is needed to
not all sputum sample pairs exhibited reported that use of endotracheal tubes determine if ventilator-associated
quantifiable growth (7). These data support with subglottic suction capability pneumonia and related pulmonary
complication rates can be reduced by
using an above-the-cuff suction inner
Table 3. Separate and combined normal flora (19 pairs) and pathogen (25 pairs) count cannula to decontaminate microorganisms
means for supraglottic and subglottic suction samples from the subglottic space for patients
who require mechanical ventilation via
Supraglottic Suction Subglottic Suction tracheotomy.
Samples Samples
Conclusions
Normal Pathogen Normal Pathogen
Proof-of-concept was confirmed. The
Blom tracheotomy tube with disposable
Day of tracheotomy (n = 20) 2.33 (1.22)* 2.91 (1.14) 2.00 (0.82) 2.42 (1.08) suction-above-the-cuff inner cannula
First week (n = 18) 2.78 (1.09) 2.38 (1.41) 1.56 (0.73) 2.29 (1.25)
Second week (n = 12) 2.50 (1.38) 3.17 (0.98) 2.50 (1.00) 3.57 (0.53) decontaminated microorganisms from the
Third week (n = 5) 4.00 (0.00) 3.00 (0.82) 2.00 (0.00) 3.00 (0.82) subglottic space when normal flora and
Fourth week (n = 2) 3.00 (0.00) 4.00 (0.00) 4.0 (0.00) 4.00 (0.00) pathogen data were combined. When
Combined 3.00 (1.05)† 2.76 (1.16)‡ 2.00 (0.94)† 2.84 (1.03)‡ analyzed separately there was a significant
*Values in parentheses are SD.
reduction in the subglottic space for normal
†
P = 0.0004. flora but not pathogens because not all
‡
P = 0.75. sputum sample pairs exhibited quantifiable

862 AnnalsATS Volume 12 Number 6 | June 2015

 BRIEF COMMUNICATION

growth. Use of the Blom tracheotomy tube
with suction-above-the-cuff inner cannula
corroborates a small but growing body of
knowledge (2–5) that suction-above-the-
cuff tracheotomy tubes have the potential
to reduce supra- versus subglottic
colonization with microorganisms. By
decreasing colonization, potentially
deadly intrapulmonary infections may be
reduced. These results suggest an urgency
to further evaluating the potential of this
type of tube. n
Author disclosures are available with the text
of this article at www.atsjournals.org.

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