Dysphagia 18:32–38 (2003)
DOI: 10.1007/s00455-002-0081-4
Simultaneous Modified Barium Swallow and Blue Dye Tests:
A Determination of the Accuracy of Blue Dye Test
Aspiration Findings
Therese M. O’Neil–Pirozzi, ScD, CCC-SLP,1,2 Deborah J. Lisiecki, BS, OTR/L,2
K. Jack Momose, MD, FRACP, FRCR,1,2 Jennifer J. Connors, BS, OTR/L,2 and
Mary P. Milliner, BA, AAS, RRT2
Department of Speech-Language Pathology and Audiology, 1Northeastern University, Boston, Massachusetts, and 2Spaulding Rehabilitation
Hospital, Boston, Massachusetts, USA
Abstract. The overall objective of this pilot study was
to determine blue dye test reliability and validity for
the identification of aspiration of secretions, food,
and/or drink in 50 simultaneously administered blue
dye (BDT) and modified barium swallow (MBS) tests
of tracheostomized individuals. With the MBS as an
objective test of aspiration, BDT sensitivity and
specificity identifying aspiration were less than 80%
and 62%, respectively. Certain tracheostomy tube
conditions and food consistencies were associated
with more accurate BDT aspiration results than
others. Characteristics of the aspiration episodes,
interpretation of the results, and needs for further
research are discussed.
Key words: Aspiration — Blue dye — Tracheostomy
— Videofluoroscopy — Dysphagia — Deglutition —
Deglutition disorders.
Individuals who have tracheostomies are described as
being at increased risk for swallowing problems [1,2].
These problems include decreased swallow and cough
reflexes [3–6], decreased laryngeal elevation and an-
terior rotation [7], and reduced glottic closure [8]. The
presence of any or all of these problems may result in
aspiration [3,9–11], which a recent study of acute care
tracheostomized patients concluded is not caused by
Correspondence to: Therese M. O’Neil–Pirozzi, Sc.D., Department
of Speech–Language Pathology and Audiology, Northeastern
University, 103 Forsyth Building, Boston, MA 02115, USA.
1 Telephone: (617) 373-5750; E-mail: toneilpi@lynx.dac.neu.edu
the tracheostomy or tracheostomy tube per se but by
other factors such as patient medical status and
neurological condition [12]. Recurrent aspiration may
be associated with aspiration pneumonia, which is
more common in medically vulnerable populations
than medically stable ones [9,11,13].
Blue dye tests have been used to assess as-
piration in individuals with a tracheostomy since the
1970s. In the original blue dye test, the Evans Blue
Dye Test (EBDT), drops of Evans blue dye are
placed on the tongue every four hours and the tra-
chea is suctioned at set intervals; blue-tinged tra-
cheal secretions suggest aspiration [14]. The
Modified Evans Blue Dye Test (MEBDT) is con-
ducted similarly but with blue food coloring mixed
into semisolid food and liquids [2]. Currently, blue
dye tests are used (1) as an aspiration screening tool
prior to an objective test of swallowing [11,15], (2)
because a clinical team feels that their at-risk patient
cannot tolerate an objective swallowing assessment,
(3) and/or because of lack of easy, timely access to
an objective swallowing assessment [11,15,16]. Ad-
vantages of blue dye tests include the following: they
can be conducted at the patient’s bedside and in a
timely fashion, they are relatively inexpensive, with
as few as one team member and only suctioning
equipment needed [17], and they do not expose the
patient to any radiation [11,18].
Blue dye test (BDT) accuracy has been ques-
tioned since the 1980s [19]. It was first investigated in
a 1995 retrospective study of five subjects who re-
ceived the MEBDT, followed by an objective test of
swallowing—either a modified barium swallow
T.M. O’Neil–Pirozzi et al.: Determination of Blue Dye Test Aspiration Accuracy
(MBS) study, also known as videofluoroscopy, or a
fiberoptic endoscopic evaluation of swallowing
(FEES) [2]—using methods which were subsequently
considered flawed [20,21]. Flaws included a small
number of subjects and widely ranging time intervals
between procedures within and across subjects.
A 1999 prospective study to determine if MBS
aspiration corresponded with simultaneous MEBDT
aspiration across 20 subjects and three per os (oral)
consistencies reported that the MEBDT had a 50%
false-negative error rate [16]. That is, the MEBDT
identified all four cases of greater than trace aspira-
tion (10% or more of the bolus) and failed to identify
all four cases of trace aspiration (less than 10% of the
bolus). However, because subjects were not suctioned
following a swallow if aspiration was not observed on
MBS, it is not known if absence of aspiration on
MBS corresponded with the same on MEBDT. Also,
results were not analyzed separately for each per os
consistency.
Based on simultaneous MBS–BDT aspiration
results of a 2001 study in which 20 subjects were
presented one per os consistency, BDT sensitivity was
45% [95% confidence interval (CI) = ±8%] and
specificity was 100% [17]. The authors discussed that
positive BDT aspiration results provide useful infor-
mation but that negative BDT aspiration results
should be viewed cautiously. Although mechanisms
to explain false negative BDT results were not of-
fered, the authors discussed the possibility of a re-
vised, more accurate BDT protocol with continued
research.
In summary, clinicians administer blue dye
tests to detect aspiration without strong evidence of
their accuracy. The primary purpose of this pilot
study was to determine the accuracy of the BDT
across 50 tracheostomized patient assessments. The
null hypothesis was that aspiration results of simul-
taneous MBS and BDT procedures would be unre-
lated. The experimental hypothesis was that
aspiration results of simultaneous MBS and blue dye
procedures would be identical across the 50 assess-
ments—that is, that identification of aspiration dur-
ing each MBS would correspond to identification of
aspiration during the simultaneous BDT and that
absence of aspiration during each MBS would cor-
respond to absence of aspiration during the simulta-
neous BDT. In the event that MBS and BDT
aspiration results were not identical across assess-
ments, the secondary purpose of this study was to
identify tracheostomy tube conditions, per os con-
sistencies, and characteristics of aspiration which
were associated with MBS–BDT aspiration agree-
ment.
33
Materials and Methods
Subjects
Subjects completed 50 simultaneous MBS–BDT procedures. Be-
cause the agreement between aspiration results of each of the 50
MBS–BDT studies was independent of the agreement between
aspiration results of the other 49 simultaneous procedures, subjects
were allowed to participate in this study up to three different times.
Thirty-seven acute rehabilitation hospital tracheostomized inpa-
tients participated in this study. A patient was eligible for study
participation after being referred for a BDT. Subject ages ranged
from 22 years 5 months to 87 years 5 months, with a mean age of
55 years 3 months. Twenty-six subjects (70%) were male, and 11
subjects (30%) were female. Subjects had anatomic, cardiovascular,
neuromuscular, and/or pulmonary medical diagnoses.
Based on the subject’s overall medical condition and the
reasons for the BDT referral, each subject’s clinical team deter-
mined the tracheostomy tube conditions under which each MBS–
BDT study was completed. High aspiration-risk patients, whose
cuffed tracheostomy tubes were inflated to reduce risk for deeper
aspiration below the inflated cuff, were included as subjects so that
BDT accuracy in identifying aspiration in these patients could be
investigated.
Tracheostomy tube inner diameters ranged from 5 to 8.5
mm; outer diameters ranged from 7 to 12.6 mm. During 32 of the
50 studies (64%), the tracheostomy tube was nonfenestrated. The
tracheostomy tube was cuffed during 33 of the 50 studies (66%),
with the cuff deflated during 30 of these 33 studies (91%). During 6
of the 50 studies (12%), the tracheostomy tube was unoccluded;
during 32 of the 50 studies (64%), a speaking valve was worn; and
during 12 of the 50 studies (24%), the tracheostomy tube was
buttoned.
Procedures
All MBS studies were conducted by a radiologist and a speech-
language pathologist (SLP), each with over 10 years of instru-
mental swallowing diagnostic experience. For multiple years prior
to this study, the clinicians conducted MBS studies according to
institutional protocol. These clinicians were trained in and deemed
competent to follow the MBS protocol for this study. All simul-
taneous BDT studies were conducted by an occupational therapist
(OT) and a respiratory therapist (RT), each with over 5 years of
clinical swallowing experience. For multiple years prior to this
study, the clinicians conducted BDT studies according to inter-
disciplinary institutional protocol. They were trained in and
deemed competent to follow the BDT protocol for this study.
Prior to the initiation of each MBS–BDT study, a lemon
glycerin swab was dipped in liquid barium and blue food coloring
for secretions assessment, and 6–8-oz servings of liquid barium-
mixed pureed solid, thick nectar liquid, and thin liquid consistencies
were each colored with 6–8 drops of blue food coloring. Sequence of
stimulus presentations was: lemon glycerin swabbing to bilateral
anterior faucial arches (4–5 strokes per side) and tongue (3–5
strokes), pureed solids (5 cc), thick nectar liquids (5 cc), and thin
liquids (5 cc). Based on his or her judgment of how well a subject
was tolerating the research protocol, any participating clinician
could terminate the subject’s participation in the study at any time.
For each consistency presented, the radiologist and SLP each
independently documented presence (+) or absence ()) of aspira-
tion; rated airway entry using the Penetration–Aspiration (P–A)
34 T.M. O’Neil–Pirozzi et al.: Determination of Blue Dye Test Aspiration Accuracy
scale, an 8-point ordinal scale which describes increasing severities
of penetration (points 2–5) and aspiration (points 6–8) events (point
1 = no airway entry) [22]; and quantified amount aspirated as trace
or greater than trace. At the end of each study, the two MBS cli-
nicians compared their judgments. Interrater discrepancies were
documented and then discussed until they were resolved. During 10
of the 50 studies (20%), a third clinician independently judged
subject MBS performance for (+/)) aspiration.
Following the videofluoroscopic observation of each stim-
ulus presented, the RT completed tracheal suctioning. Then, the
OT and RT each independently examined the suctioned secretions
for blue coloration against a well-lit white background and docu-
mented presence or absence of blue, representing (+/)) aspiration.
After independently making each aspiration judgment, the OT and
RT compared their judgments. Interrater discrepancies were doc-
umented and then discussed until they were resolved. Throughout
each study, BDT clinicians were blinded to the subject’s MBS
performance, and MBS clinicians were blinded to the subject’s
BDT performance.
Analysis
The experimental hypothesis was tested by analyzing the data from
the 50 joint MBS–BDT studies in two different ways. First, to
compare the results of this study with previously published results
[16], overall agreement between MBS–BDT aspiration judgments
was analyzed across the 50 joint studies based on whether or not
presence or absence of any aspiration identified during each MBS
agreed with presence or absence of any aspiration identified during
the corresponding BDT, regardless of whether or not consistencies
aspirated during the MBS and the joint BDT were the same. For
example, if a subject’s MBS performance indicated aspiration on
pureed solids and thick liquids and BDT performance indicated
aspiration on thin liquids, the joint studies agreed regarding pres-
ence of overall aspiration.
Second, to determine the ability of the BDT to identify
consistency-specific aspiration, agreement between the first MBS
consistency aspirated and the first BDT consistency aspirated was
analyzed across the 50 joint studies. For example, if a subject’s first
MBS aspiration was on pureed solids and the first BDT aspiration
was on thin liquids, the joint studies did not agree regarding first
consistency aspiration.
With the MBS as the objective measure of aspiration, the
four possible MBS–BDT aspiration agreement outcomes for both
types of analyses were as follows: (1) MBS and BDT positive for
aspiration, (2) MBS and BDT negative for aspiration, (3) MBS
positive for aspiration and BDT negative for aspiration (false
negative BDT finding), and (4) MBS negative for aspiration and
BDT positive for aspiration (false positive BDT finding). Sensi-
tivity, specificity, positive predictive values, and negative predictive
values of the BDT were calculated. Associations between BDT
aspiration accuracy and tracheostomy tube conditions, per os
consistencies, aspiration severity, and aspiration amount were in-
vestigated descriptively and/or statistically using Fisher’s exact test
and the exact Kruskal–Wallis test. Statistical significance was set at
p<0.05.
Characteristics of overall MBS aspiration performance were
analyzed using the P–A scale score [22] and aspiration amount
which represented each subject’s worst performance across con-
sistencies tested. Characteristics of first-consistency MBS aspira-
tion performance were analyzed using the P–A scale score and
aspiration amount which represented each subject’s performance
on the first consistency aspirated.
Results
Aspiration was present during 21 of the 50 MBS
studies (42%); aspiration was absent during the other
29 MBS studies (58%). Aspiration was present during
19 of the 50 BDT studies (38%); aspiration was ab-
sent during the other 31 BDT studies (62%).
Overall MBS–BDT Aspiration Agreement
A descriptive analysis of aspiration agreements across
simultaneous MBS and BDT procedures revealed
that overall aspiration results agreed in 36 of the 50
joint studies (72%) and disagreed during the other 14
studies (28%). More specifically, in 13 of the 36 joint
studies (36%) where overall aspiration results agreed,
aspiration was present on at least one consistency
tested during both the MBS and the BDT. In the
other 23 cases of agreement (64%), aspiration was
absent across consistencies during both procedures.
In eight of the 14 joint studies where the aspiration
results disagreed (57%), the MBS identified aspiration
on at least one consistency tested while the BDT did
not. In the other six cases of disagreement (43%), the
BDT identified aspiration while the MBS did not.
With the MBS as an objective measure of as-
piration, the BDT had a sensitivity of 79.3% (95%
CI = 60.3%–92%) and a specificity of 61.9% (95%
CI = 38.4%–81.9%). The positive predictive value of
the BDT was 74.2% (95% CI = 55.4%–88.1%), and
its negative predictive value was 68.4% (95%
CI = 43.4%–87.4%),
First-Consistency MBS–BDT Aspiration Agreement
A descriptive analysis of aspiration agreements across
simultaneous MBS and BDT procedures based on the
first consistency aspirated during each procedure re-
vealed that first-consistency aspiration results agreed
in 29 of the 50 joint studies (58%) and disagreed in
the other 21 studies (42%). More specifically, in six of
the 29 simultaneous studies (21%) where first-con-
sistency aspiration judgments agreed, presence of first
BDT consistency aspiration corresponded to first
MBS consistency aspiration. In the other 23 cases of
agreement (79%), aspiration was absent across con-
sistencies in both procedures. In 15 of the 21 simul-
taneous studies where first-consistency aspiration
results disagreed (71%), the MBS identified aspiration
on a particular consistency that the BDT did not. In
the other six cases of first-consistency aspiration
T.M. O’Neil–Pirozzi et al.: Determination of Blue Dye Test Aspiration Accuracy
disagreement (29%), the BDT identified aspiration on
a particular consistency that the MBS did not.
With the MBS as an objective measure of as-
piration, the BDT had a sensitivity of 79.3% (95%
CI = 60.3%–92%) and a specificity of 28.6% (95%
CI = 11.3%–52.2%). The positive predictive value of
the BDT was 60.53% (95% CI = 43.4%–76%), and
its negative predictive value was 50% (95% = 21.1%–
78.9%).
Tracheostomy Tube Conditions and MBS–BDT
Aspiration Agreement
A descriptive analysis was done of overall aspiration
agreement across MBS–BDT studies with each of five
tracheostomy tube variables: tracheostomy tube in-
ner diameter, tracheostomy tube outer diameter,
tracheostomy tube type (fenestrated/nonfenestrated),
cuff status (inflated/deflated/cuffless), and occlusion
status (unoccluded/speaking valve/buttoned). Re-
garding cuff status, 24 of the 36 studies (67%) in
which overall MBS–BDT aspiration results agreed
were completed with a deflated cuff; the other 12 of
these studies (33%) were completed with a cuffless
tracheostomy tube. Three of the 14 joint studies
(21%) in which overall MBS–BDT aspiration results
disagreed were the three studies completed with an
inflated cuff. Regarding occlusion status, 3 of the 36
studies (8.5%) in which overall MBS–BDT aspiration
results agreed were completed with an unoccluded
tracheostomy tube; 26 of these studies (72%) were
completed with a speaking valve, and the other 7
studies (19.5%) were completed with a buttoned tra-
cheostomy tube.
A statistical analysis with each of the five
tracheostomy tube variables using Fisher’s exact test
revealed that there were no statistically significant
differences in overall MBS–BDT aspiration agree-
ment across subjects based on inner tracheostomy
tube diameter (p = 0.75), outer tracheostomy tube
diameter (p = 0.58), and presence/absence of fenes-
tration (p = 0.53). Differences based on cuff status
were statistically significant (p = 0.02) such that
overall MBS and BDT aspiration judgments were
more likely to agree when a cuff was deflated than
when it was inflated or when the tracheostomy tube
was cuffless. Differences based on occlusion status
approached statistical significance (p = 0.11).
A descriptive analysis was done of aspiration
agreement across MBS–BDT studies based on the first
consistency aspirated during each procedure with each
of two tracheostomy tube variables: cuff status and
occlusion status. Regarding cuff status, 21 of the 29
35
studies (72%) in which first MBS and first BDT con-
sistency aspiration results agreed were completed with
a deflated cuff; the other 8 of these studies (28%) were
completed with a cuffless tracheostomy tube. Re-
garding occlusion status, 2 of the 29 studies (7%) in
which first MBS and first BDT consistency aspiration
results agreed were completed with an unoccluded
tracheostomy tube; 23 of these 29 studies (79%) were
completed with a speaking valve, and the other 4
studies (14%) were with a buttoned tracheostomy tube.
A statistical analysis with each of these two tracheos-
tomy tube variables using Fisher’s exact test revealed
that there were statistically significant differences in
MBS–BDT aspiration agreement based on cuff status
(p = 0.0005) such that first-consistency MBS–BDT
aspiration judgments were more likely to agree when a
cuff was deflated than when it was inflated or when the
tracheostomy tube was cuffless. Differences based on
occlusion status were also statistically significant
(p = 0.03) such that first-consistency MBS–BDT as-
piration judgments were more likely to agree when a
speaking valve was worn than when the tracheostomy
tube was unoccluded or buttoned.
Per Os Consistencies and MBS–BDT Aspiration
Agreement
During 13 of the 36 studies (36%) in which overall
MBS–BDT aspiration results agreed, aspiration was
present on at least one consistency during both pro-
cedures. The frequency with which each consistency
was aspirated during these 13 MBS studies compared
with during each simultaneous BDT was different
across subjects: Thick nectar liquids was the MBS
consistency aspirated most frequently (39%), fol-
lowed by thin liquids (26%), pureed solids (22%), and
secretions (13%). Pureed solids was the BDT consis-
tency aspirated most frequently (37%), followed by
secretions and thin liquids (26% each), and thick
nectar liquids (11%). Statistical analyses using the
exact Kruskal–Wallis test revealed that there were no
statistically significant differences in overall MBS–
BDT aspiration agreement across subjects based on
consistency (p = 0.20) and that there was no statis-
tically significant order effect for consistencies tested
during the MBS or during the BDT (p = 0.20).
During the six studies in which first-consis-
tency MBS and BDT aspiration results agreed that
aspiration was present, pureed solids was the con-
sistency aspirated most frequently (50%), followed by
secretions, thick nectar liquids, and thin liquids
(16.67% each). Descriptively, agreement regarding
presence of aspiration across procedures was three
36
Table 1. P–A scale score breakdown in the 23 studies with no MBS
or BDT aspiration
P–A scale score No. of subjects
1 12
2 3
3 2
4 3
5 3
times as great for pureed solids as it was for each of
the other three consistencies; statistical significance of
this consistency-specific difference could not be cal-
culated with only six studies.
Severity of Aspiration and MBS–BDT Aspiration
Agreement
During 6 of the 13 studies (46%) in which overall
MBS–BDT aspiration results agreed that aspiration
was present, subjects received a P–A scale score [22]
of 7; during the other 7 of these studies (54%), sub-
jects received a P–A scale score of 8. During the 23
studies in which MBS–BDT aspiration results agreed
that aspiration was absent, subjects received P–A
scale scores of 1–5 (Table 1). A statistical analysis
using Fisher’s exact test revealed that there were no
statistically significant differences in the distribution
of P–A scale aspiration scores based on whether or
not overall aspiration identified during the MBS
procedure was also identified during the simultaneous
BDT procedure across consistencies (p = 0.9995).
During the 6 studies in which first-consistency
MBS and BDT aspiration results agreed that aspi-
ration was present, three subjects (50%) received a P–
A scale score of 7, and the other three subjects (50%)
received a P–A scale score of 8. A statistical analysis
using Fisher’s exact test revealed that there were no
statistically significant differences in the distribution
of P–A scale aspiration scores based on whether or
not first-consistency MBS aspiration was also iden-
tified during the simultaneous BDT procedure
(p = 0.9995).
Amount of Aspiration and MBS–BDT Aspiration
Agreement
During the 13 studies in which overall MBS–BDT
aspiration results agreed that aspiration was present,
the greatest amount aspirated was greater than trace.
In seven of the eight cases (88%) in which aspiration
T.M. O’Neil–Pirozzi et al.: Determination of Blue Dye Test Aspiration Accuracy
was present during the MBS but not during the joint
BDT, the greatest amount aspirated was greater than
trace; in the eighth case (12%), the greatest amount
aspirated was a trace amount.
During the 6 studies in which first-consistency
MBS–BDT aspiration results agreed that aspiration
was present, the amount aspirated was greater than
trace. In 13 of the 15 cases (87%) in which the joint
BDT did not identify the first MBS consistency as-
pirated, the amount of MBS aspiration was greater
than trace; in the other two cases (13%), the amount
aspirated was a trace amount.
Interrater Aspiration Agreement for MBS and BDT
Studies Before Discussion
There was 100% agreement between independent
judgements of the two MBS clinicians regarding
presence, absence, and amount of aspiration across
MBS studies. A third MBS clinician judged presence
and absence of aspiration during 10 of the 50 studies
(10%); there was 100% agreement across all three
MBS clinicians during these 10 studies. There was
98% agreement between independent judgements of
the two BDT clinicians regarding presence and ab-
sence of aspiration across BDT studies. During one
study, the two clinicians had to resolve one aspiration
judgement discrepancy; following discussion, the cli-
nicians agreed that aspiration was present.
There was 100% agreement between the two
MBS clinicians’ P–A scale scores [22] of aspiration
severity across the 21 studies in which aspiration was
present. Regarding the 29 studies in which aspiration
was absent, there was 100% agreement between the
two MBS clinicians’ P–A scale scores across the 13
studies with no airway entry, and there was 81%
agreement between their P–A scale scores of pene-
tration severity across the 16 studies with penetration
(n = 13). In each of the three cases of penetration
severity disagreement, the interrater discrepancy
consisted of a one scale score difference regarding
severity of penetration.
Discussion
The primary purpose of this pilot study was to de-
termine the accuracy of the BDT across 50 trach-
eostomized patient assessments. With the MBS as an
objective test of presence/absence of aspiration, BDT
sensitivity and specificity identifying presence/ab-
sence of aspiration were less than 80% and 62%, re-
T.M. O’Neil–Pirozzi et al.: Determination of Blue Dye Test Aspiration Accuracy
spectively. That is, the BDT did not correctly identify
approximately 20% of tracheostomized patients who
were aspirating and at least 38% of tracheostomized
patients who were not aspirating. Also, evidence
supporting the ability of the BDT to accurately pre-
dict presence and absence of aspiration was lacking.
These findings expand upon findings of previous
studies [16,17] which raise concerns about the BDT.
While the results of this study generate serious
doubt about the accuracy of the BDT, the confidence
intervals (CI) associated with obtained sensitivity,
specificity, and predictive BDT values are too wide to
conclude definitively that the BDT should not be
used. For example, overall MBS–BDT aspiration
agreement analysis revealed that the BDT had a
sensitivity of 79.3% (95% CI = 60.3%–92%) and a
specificity of 61.9% (95% CI = 38.4%–81.9%). Con-
fidence intervals should be narrow enough to elimi-
nate one of the possible conclusions [23,24]—in this
case that the BDT is an acceptable bedside screening
tool for aspiration or that it is not. BDT sensitivity of
92% and specificity of 81.9% would make the BDT a
more acceptable bedside screening tool for aspiration
than traditional clinical bedside swallow evaluations
which are reportedly no more than 66% accurate
screening for aspiration [25–27]. BDT sensitivity of
60.3% and specificity of 38.4% would make the BDT
an unacceptable tool.
We did not expect the BDT to identify aspi-
ration that was not identified by the MBS during 6 of
the 50 joint studies (12%). One possible explanation
for this finding is false negative MBS results; another
possible explanation is false positive BDT results.
Given that the MBS is accepted as an objective test of
aspiration [11,15,28], the idea of false negative BDT
results is the more likely explanation for the (+)
MBS/()) BDT aspiration disagreements than the idea
of false positive MBS results. However, both possi-
bilities warrant further investigation.
Logemann [11] cautions against definitively
calling BDT results positive for aspiration when small
amounts of blue-tinged secretions are suctioned from
a patient’s tracheostomy for the first time several
hours after stimulus presentation and, alternatively,
suggests that this suctioned blue dye may be a more
direct consequence of the impact of gravity on nor-
mal secretion flow and keeping the trachea moist.
Given that the MBS and BDT studies were done si-
multaneously, it is unlikely that gravity accounts for
these six ())MBS/(+)BDT aspiration results.
One possible mechanism to account for false
positive BDT aspiration results relates to tracheal
suctioning that is done as a routine part of the BDT
to identify presence of aspiration. That is, perhaps the
37
negative pressure created by the suction catheter in-
serted into the trachea is enough to pull material lo-
cated above the laryngeal vestibule and/or at or
above the vocal folds below the folds during suc-
tioning, thereby causing aspiration of material that
may not have been aspirated otherwise. Some of the
MBS P–A scale [22] score results of this study provide
initial support for this possibility. In three of this
study’s six ())MBS/(+)BDT aspiration cases (50%),
BDT aspiration was not associated with simultaneous
or previous MBS penetration or aspiration. In two of
these six cases (33%), BDT aspiration was associated
with simultaneous MBS penetration. In the sixth case
(17%), BDT aspiration was associated with simulta-
neous as well as previous MBS penetration. Perhaps
these positive BDT aspiration results reflect aspira-
tion that occurred as a direct result of tracheal suc-
tioning and so were not viewed during the joint MBS.
Whether or not tracheal suctioning can cause aspi-
ration has never been investigated but should be.
Videofluoroscopically observing tracheal suctioning
is one method which might be used to examine this
possibility.
The secondary purpose of this study was to
identify tracheostomy tube conditions, per os con-
sistencies, and/or characteristics of aspiration which
were associated with MBS–BDT aspiration agree-
ment. Results revealed that certain tracheostomy
tube conditions (cuff deflation, use of speaking valve)
and food consistencies (pureed solids) were each as-
sociated with more accurate BDT aspiration results
than others. No associations were found between
severity of aspiration, as measured by the P–A scale
[22], and MBS–BDT aspiration agreement. However,
of the 23 cases in which the joint studies agreed that
aspiration was absent, 11 (48%) received P–A scale
scores of 2–5, representing increasing severities of
penetration (Table 1). These subjects’ P–A scale
scores highlight an inherent BDT limitation, that
being its inability to identify instances of laryngeal
penetration, which may put an individual at risk for
later aspiration of the per os consistency penetrated
and/or of a subsequent consistency presented [29].
Also, the previously reported association between
amount of aspiration and ability of a BDT to identify
aspiration [16] was not supported by the results of
this study. Most significantly, the BDT did not
identify several cases of greater-than-trace MBS as-
piration.
This study was the largest one to date inves-
tigating the ability of the BDT to detect aspiration
accurately. The results of this study and other related
preliminary/pilot studies [16,17] support the need for
a statistically powerful, full-scale inquiry of BDT
38 T.M. O’Neil–Pirozzi et al.: Determination of Blue Dye Test Aspiration Accuracy
reliability and validity for the identification of aspi-
ration of secretions, food, and/or drink in this vul-
nerable population. Examination of associations
between BDT accuracy identifying aspiration and
tracheostomy tube conditions, per os consistencies,
and characteristics of aspiration should be continued.
In-depth investigation of these variables may lead to
a revised BDT protocol which would provide clini-
cians with a means of accurately and confidently
identifying tracheostomized patient aspiration at the
bedside. The potentially negative impact of tracheal
suctioning on aspiration should also be investigated
and may lead to additional BDT protocol revisions.
In summary, being able to determine if a
tracheostomized patient is aspirating is of great
clinical importance. This information impacts on
such clinical decisions as when such a patient who is
not eating or drinking may begin to do so and when
diet consistencies may be safely upgraded. Clinicians
commonly administer a BDT at the bedside of the
tracheostomized patient to investigate aspiration risk.
However, based on the results of this pilot study,
these patients should be evaluated using more reliable
and valid procedures, such as videofluoroscopy and
videoendoscopy, whenever possible.
Acknowledgments. This study was supported by grant NIH R03
DC 3848. We thank Denise Ambrosi, Christopher Hirsch, Rebecca
Leonard, Judi Martinson, and Heather Weston for their contri-
butions to this project.
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