Australian Critical Care 29 (2016) 132137

Contents lists available at ScienceDirect

Australian Critical Care

journal homepage: www.elsevier.com/locate/aucc

Research paper

Clinical indicators associated with successful tracheostomy cuff

deation
Lee N. Pryor BASc a,b, ,
Elizabeth C. Ward PhD b,c ,
Petrea L. Cornwell PhD d,e ,
Stephanie N. OConnor MNSc a,f ,
Marianne J. Chapman MD, PhD a,f
a
Royal Adelaide Hospital, Intensive Care Unit, SA, Australia
b
The University of Queensland, School of Health & Rehabilitation Sciences, QLD, Australia
c
Centre for Functioning & Health Research (CFAHR), QLD, Australia
d
The Prince Charles Hospital, Metro North Hospital and Health Service, QLD, Australia
e
School of Applied Psychology, Menzies Health Institute Queensland, Grifth University, QLD, Australia
f
The University of Adelaide, School of Medicine, SA, Australia

article information a b s t r a c t

Article history: Background: Tracheostomy cuff deation is a necessary stage of the decannulation pathway, yet the
Received 28 August 2015 optimal clinical indicators to guide successful cuff deation are unknown.
Received in revised form 9 December 2015 Objectives: The study aims were to identify (1) the proportion of patients tolerating continuous cuff
Accepted 12 January 2016
deation at rst attempt; (2) the clinical observations associated with cuff deation success or failure,
including volume of above cuff secretions and (3) the predictive capacity of these observations within a
Keywords:
heterogeneous cohort.
Clinical indicators
Methods: A retrospective review of 113 acutely tracheostomised patients with a subglottic suction tube
Criteria
Cuff deation
in situ was conducted.
Decannulation Results: Ninety-ve percent of patients (n = 107) achieved continuous cuff deation on the rst attempt.
Subglottic suction The clinical observations recorded as present in the 24 h preceding cuff deation included: (1) medical
Tracheostomy stability, (2) respiratory stability, (3) fraction of inspired oxygen 0.4, (4) tracheal suction 12 hourly,
(5) sputum thin and easy to suction, (6) sputum clear or white, (7) moderate cough strength, (8) above
cuff secretions 1 ml per hour and (9) alertness eyes open to voice. Using the presence of all 9 indicators
as predictors of successful cuff deation tolerance, specicity and positive predictive value were 100%,
although sensitivity was only 77% and negative predictive value 19%. Renement to a set of 3 clinically
driven criteria (medical and respiratory stability, above cuff secretions 1 ml/h) provided high specicity
(100%), sensitivity (95%), positive predictive value (100%) and an improved negative predictive value
(55%).
Conclusions: Key criteria can help guide clinical decision-making on patient readiness for cuff deation.
Crown Copyright 2016 Published by Elsevier Ltd on behalf of Australian College of Critical Care
Nurses Ltd. All rights reserved.

1. Introduction

Evidence based criteria for progressing patients with a

Abbreviations: FiO2 , fraction of inspired oxygen; PPV, positive predictive value;
NPV, negative predictive value.
Corresponding author at: Speech Pathology Department, Royal Adelaide
Hospital, North Terrace, Adelaide, SA 5000, Australia. Tel.: +61 882225524;
fax: +61 882225924.
E-mail address: lee.pryor@sa.gov.au (L.N. Pryor).
tracheostomy towards decannulation is limited, despite the proce-
dural frequency of tracheostomy tube insertion in intensive care
settings.1 Interpretation of existing research is difcult, in part,
due to the heterogeneity of patient populations managed in crit-
ical care,2 as well as the multitude of factors inuencing patient
outcomes.3 Furthermore, the majority of existing research has

http://dx.doi.org/10.1016/j.aucc.2016.01.002
1036-7314/Crown Copyright 2016 Published by Elsevier Ltd on behalf of Australian College of Critical Care Nurses Ltd. All rights reserved.
 L.N. Pryor et al. / Australian Critical Care 29 (2016) 132137
focused on establishing indicators for decannulation4,5 as opposed
to key steps in the decannulation pathway, such as cuff deation
tolerance.
Once the underlying reason for tracheostomy insertion has
resolved and mechanical ventilation is no longer required, the fac-
tors that have been put forward as inuencing decision-making
for tube removal include, a patients conscious state, oxygen lev-
els, cough effectiveness and both pulmonary and oral secretions.5,6
The ability to tolerate prolonged occlusion of the tracheostomy
via capping or corking has been suggested as an indicator of suit-
ability for decannulation.4,5 There is, however, a clinical debate
around the safety of tracheostomy occlusion, due to the poten-
tial for increased airway resistance from breathing through a
reduced tracheal space.7,8 There also remains the debate as to
the best decannulation pathway,9 with some of the more com-
monly described processes including, cuff deation only (that
is, cuff deation followed by decannulation),10 downsizing and
occlusion,6,1012 the use of fenestrated tubes13 and the placement
of a one-way valve.12,14
The factor that is common to all of these pathways, and a
necessary rst stage in any progression towards decannulation,
is tracheostomy cuff deation. This is where airow through the
upper airway, including the vocal cords, is restored.15 Studies to
date documenting cuff deation in clinical practice have only exam-
ined mechanically ventilated patients, for whom cuff deation may
restore speech16,17 or promote weaning through increased aper-
ture for airow.18 There is yet to be any systematic research that
identies the patient characteristics that can serve as reliable pre-
dictors for determining their ability to tolerate continuous cuff
deation. At present, statements in clinical practice guidelines are
based only on clinical consensus.19,20 Such guidelines suggest that
considerations prior to initial cuff deation should include the abil-
ity to cope with oral secretions in a setting of respiratory and
medical stability.
The ability for patients to manage oral secretions is an important
component of these criteria. Oropharyngeal secretions can con-
tain pathogenic bacteria which, if aspirated into the lower airways,
may cause pneumonia.21 Premature cuff deation in someone who
does not tolerate secretions, due to either copious secretion pro-
duction or to the presence of dysphagia, may lead to excessive
aspiration and respiratory deterioration. This hinders their progres-
sion towards decannulation. Conversely, any unnecessary delay to
commencing cuff deation may be detrimental to a patients phys-
iological and psychosocial recovery due to the deferred return to
verbal communication and oral intake.22
At present, determining a patients ability to manage their sec-
retions is typically based on subjective observations, including the
visual inspection of the amount of oral secretions and the frequency
of suctioning. However, the increased clinical use of tracheostomy
tubes enabling subglottic suction may provide greater opportunity
to establish more objective, volumetric monitoring of above cuff
secretions to inform clinical decisions. Tracheostomy tubes with
subglottic suction lines enable removal of secretions from above
the inated cuff23 and have been shown to reduce the amount of
normal ora in the subglottic space.24 A large amount of secreti-
ons removed from above the cuff could indicate a poor swallow.
Minimal accumulated secretions may indicate adequate secretion
management and those patients most likely to protect their airway
with the cuff deated.
In light of the absence of validated clinical criteria to predict
successful cuff deation, the current study set out to investigate
factors related to successful continuous cuff deation in a cohort
of acute patients with a tracheostomy, each with a subglottic suc-
tioning tube in situ. The specic aims were: (1) to determine the
current proportion of success on initial continuous cuff deation,
(2) to describe the common clinical observations associated with
133
Table 1
Patient factors commonly considered prior to cuff deation.
Characteristics considered
Medical status (stable or improving)
Respiratory status (stable or improving)
Oxygenation (FiO2 0.4)a
Cough strength (moderate)
Patient alertness (eyes open to voice)
Sputum colour (clear or white)
Sputum nature (thin and easy to suction)
Tracheal suction frequency (12 hourly)
Above cuff secretions (1 ml per hour)
a
FiO2 , fraction of inspired oxygen.
continuous cuff deation success or failure, including volume of
above cuff secretions, and (3) to explore the sensitivity, specicity
and predictive value of these clinical indicators within a heteroge-
neous cohort.
2. Methods and materials
A retrospective case-note and chart audit was conducted on all
patients who underwent surgical or percutaneous tracheostomy at
the Royal Adelaide Hospital (RAH), a 640 bed acute tertiary hospi-
tal, between January and December 2009. The study was conducted
in accordance with The Code of Ethics of the World Medical Asso-
ciation (Declaration of Helsinki) and approval was obtained from
the RAH Human Research Ethics Committee to access all informa-
tion recorded within the medical records, including progress notes,
operation records, intensive care and ward observation charts. This
study is a secondary analysis of a larger cohort of patients. The pat-
terns of oral intake commencement, enteral nutrition cessation,
and decannulation for the heterogeneous cohort have also been
reported.25
2.1. Participants
All patients recorded as having a tracheostomy in situ were
identied through Diagnostic Related Group case-mix coding
(DRG A06), with procedural codes 41880-00 (percutaneous tra-
cheostomy), 41881-00 (open tracheostomy, temporary) or 41881-01
(open tracheostomy, permanent). These patients were cross referen-
ced with the hospital nursing records that indicated a tracheostomy
occasion of care. Patients were excluded if they had a tracheostomy
in situ on admission, had undergone a total laryngectomy, had
a mini-tracheostomy in situ, the case-notes were unavailable for
review, or if the patient had died with a cuffed tracheostomy in situ.
Data sets were also excluded if an extended length tracheostomy
was in place as these tubes do not allow subglottic suction. A cohort
of 113 patients remained for analysis (Fig. 1). All were 24 h free
from mechanical ventilation prior to the initial cuff deation trial.
2.2. Cuff deation practices
Whilst there are no set protocols or criteria for cuff deation in
the participating hospital, there are common considerations that
are discussed by the multidisciplinary tracheostomy team when
evaluating patients for tracheostomy progression which may be
applicable to cuff deation (Table 1). These are consistent with
the factors considered prior to decannulation5,6 and include the
3 parameters reported in the clinical guidelines that are relevant to
cuff deation, namely a stable or improving medical and respiratory
status, and evaluation of oral secretions.19,20 Medical/respiratory
stability in this instance refers to patients who are not showing
signs of new infection, or deterioration. A patient who is receiving
134 L.N. Pryor et al. / Australian Critical Care 29 (2016) 132137

Fig. 1. Study cohort for analysis.

antibiotics for pneumonia, for example, will be considered stable Table 2

Demographics.
or improving if they are responding to treatment.
Evaluation of oral secretions is enhanced in this facility through Gender
routine use of subglottic suctioning tracheostomy tubes, whereby Male 63% (n = 71)
Female 37% (n = 42)
the volume of above cuff secretions is measured and considered by
Insertion method
the clinical team. Above cuff aspirates reecting up to 1 millilitre Percutaneous 49% (n = 55)
(ml) of accumulated secretions per hour are viewed by members of Surgical 51% (n = 58)
the tracheostomy team as acceptable in the context of swallowing Insertion tube size
with a foreign body below the larynx. Therefore, a patient with Size 8 78% (n = 88)
Size 6 22% (n = 25)
24 ml of subglottic secretions in a 24 h period is considered a good
Reason for tracheostomy insertion
candidate for progressing to cuff deation, seen in the context of Planned head and neck surgical procedure 30% (n = 34)
other patient factors. Prolonged mechanical ventilation 41% (n = 46)
The common approach to cuff deation in the participating hos- Airway protection +/ impaired conscious state 29% (n = 33)
pital is to aim for continuous cuff deation. Reination of the cuff
will only occur if the patient is not tolerating cuff deation. The
positive predictive value (PPV) and negative predictive value (NPV).
signs of poor tolerance include frequent coughing, overt patient
The data was analysed as: (1) a grouped set of 9 indicators (Table 1)
discomfort/distress, increased sputum load and/or a clinically
and (2) a rened set of 3 criteria reecting the key parameters
important change in patient observations from baseline.13,26,27
suggested in the clinical guidelines (medical/respiratory stabil-
ity + ability to swallow oral secretions).19,20
2.3. Data collection
3. Results
The information obtained from the standardised tracheostomy
observation charts and case-notes was evaluated for the presence
The demographics of the overall cohort (n = 113) are shown
or absence of patient observations (Table 1) in the 24 h preceding
in Table 2. The median age was 53 years (1887) with a mean
initial trial of continuous cuff deation. Within this time period the
APACHE III score of 59 (SD 27). The cohort was divided into 3 groups,
overall volume (ml) of secretions removed from above the inated
according to the reason for tracheostomy insertion. These were: (1)
tracheostomy cuff was recorded, as was the frequency of tracheal
planned as part of a head and neck surgical procedure, (2) for pro-
suction. The information was collected and entered into an Excel
longed mechanical ventilation, and (3) for gross airway protection
spreadsheet by an independent research assistant with experience
+/ impaired conscious state. Prolonged mechanical ventilation
conducting clinical chart audits, with 25% of the data subsequently
was the most common reason for insertion (Table 2). The method
cross-checked by the lead investigator. An error rate of 3% was
of insertion, either percutaneous or surgical, was equivocal and the
conrmed and deemed acceptable.
majority of patients had a size 8 tube inserted.
Successful continuous cuff deation was achieved on the rst
2.4. Analysis attempt for 95% (n = 107) of the cohort. All of the patients (n = 113)
ultimately progressed to cuff deation during hospital admission at
Demographics and temporal data were reported using mean a median of 8 days post tracheostomy insertion (range 067 days)
(standard deviation), with skewed data expressed as median and with 86% of the cohort progressing to decannulation a median of 6
range. The clinical indicators associated with cuff deation success days later (range 077 days post cuff deation).
and failures were rst described as frequency counts, expressed The clinical indicators associated with initial cuff deation suc-
as percentages, and then analysed for sensitivity, specicity, cess and failures are shown in Table 3. Of those who tolerated cuff
 L.N. Pryor et al. / Australian Critical Care 29 (2016) 132137 135

Table 3
Presence of clinical indicators and proportion of cuff deation success within total group (n = 113).

Clinical indicator Total cohort (n = 113) Successful cuff Unsuccessful cuff

deation (n = 107) deation (n = 6)

n (%) n (%) n (%)

1. Medical stability 113 (100) 107 (100) 6 (100)

2. Respiratory stability 113 (100) 107 (100) 6 (100)
3. Oxygenation (FiO2 0.4) 112 (99) 106 (99) 6 (100)
4. Alertness (eyes open to voice) 102 (90) 98 (92) 4 (67)
5. Sputum colour (clear/white) 105 (93) 102 (95) 3 (50)
6. Sputum nature (thin/easy to suction) 108 (96) 105 (98) 3 (50)
7. Cough strength (moderate) 108 (96) 103 (96) 5 (83)
8. Tracheal suction frequency (12 hourly) 111 (98) 106 (99) 5 (83)
9. Above cuff aspirates (1 ml per hour) 102 (90) 102 (95) 0 (0)

Grouped indicators
Met all 9 indicators 82 (73) 82 (77) 0 (0)
Met 8 of the 9 indicators 25 (22) 24 (22) 1 (17)
Met 7 indicators 6 (5) 1 (1) 5 (83)
Met 3 indicators (1, 2 and 9) 102 (90) 102 (95) 0 (0)

Table 4
Predictive values of grouped clinical indicators: (a) set of 9 and (b) rened set of 3.

Test outcome Success of tracheostomy cuff deation

Positive Negative

(a) Application of all 9 criteria

Positive 82 (a = true positive) 0 (b = false positive)
Negative 25 (c = false negative) 6 (d = true negative)

(b) Application of 3 criteriaa

Positive 102 (a = true positive) 0 (b = false positive)
Negative 5 (c = false negative) 6 (d = true negative)
a
Medical stability, respiratory stability, above cuff aspirates 1 ml per hour.

Fig. 2. Above cuff secretions prior to initial cuff deation for the 3 patient groups
(n = 113). Scatterplot demonstrating the accumulated secretions (ml) removed from
above the inated tracheostomy cuff for each patient in the 24 h prior to cuff
deation, with the cohort (n = 113) separated according to the reason for tra-
cheostomy insertion. S = tracheostomy as part of planned head and neck surgery.
V = tracheostomy for prolonged mechanical ventilation. A = tracheostomy for airway
protection +/ impaired conscious state. NB: grey diamond denotes two patients
deation on the rst trial: 77% met all of the 9 criteria; with an
additional 22% meeting 8 of the 9 criteria, and only 1% meeting 7 of
the 9 indicators (Table 3). There were 25 patients who did not meet
all of the criteria yet still achieved successful cuff deation. The clin-
ical indicators which were not met by these individuals included
alertness (n = 9), sputum colour (n = 5), above cuff aspirates (n = 5)
and cough strength (n = 4).
Only 6 patients were unsuccessful on initial cuff deation. Of
these, 5 failed to meet multiple criteria prior to the attempt (Table 3)
and all had above cuff aspirates exceeding 24 ml in the 24 h pre-
ceding deation (Fig. 2). These patients had tracheostomies for the
following reasons: (i) part of planned head and neck surgical pro-
cedure (n = 2) or (ii) airway protection +/ conscious state (n = 4).
These patients had an older median age than the successful group
(67 years and 52 years respectively). Most failed immediately
or within 30 min of the rst attempt (n = 4), which was charac-
terised by persistent coughing and an associated tachycardia. The
remaining patients (n = 2) required cuff reination within 12 h due
to increased tracheal suction requirements overnight that was
suggestive of aspiration. All 6 patients subsequently progressed
to successful continuous cuff deation within 4 days of the rst
attempt.
The sensitivity of all 9 grouped indicators for cuff deation to
accurately identify those suitable for cuff deation, was 77%. Speci-
city, which is the ability to correctly identify those who are likely
to fail, was 100%. The PPV, or the proportion of patients correctly
identied as passing their initial cuff deation trial using all 9
indicators, was 100%. However the NPV was low (19%), reecting
that failure to meet the set of 9 indicators did not accurately predict
a persons ability to tolerate cuff deation (Table 4a).
The renement of the criteria to reect the 3 key indicators
suggested in the clinical guidelines as important for cuff deation
resulted in greater accuracy in clinical decisions (Table 3). This set
of criteria was both sensitive (95%) and specic (100%) with strong
PPV (100%) (Table 4b). The NPV was 55%. Case examination revealed
all of the false negatives were patients for whom the tracheostomy
was inserted during head and neck surgery.
4. Discussion
The current study has provided initial evidence to support
clinical indicators associated with successful tracheostomy cuff
deation in patients weaned from mechanical ventilation. Almost
all of the patients in our study tolerated continuous cuff deation
at the rst attempt. Clinicians remain divided as to the ideal dura-
tion of the initial attempt for cuff deation: intermittent trials with
planned reination; continuous cuff deation with reination only
if not tolerated; or a mix of the two approaches depending on the
patient population have all been described.4,6,13 The current data
suggests that with use of key selection criteria, the majority of
patients can progress in a single step to continuous cuff deation,
regardless of the reason for insertion.
A core set of 9 clinical observations related to the factors
previously highlighted in the literature as important precursors
to decannulation (including medical and respiratory stability,
oxygenation, consciousness, pulmonary and oral secretions, and
cough),5,6 were found to be indicative of patients likely to tol-
erate an initial cuff deation trial. This was conrmed by high
positive predictive values. While these provide a starting point to
further evaluate clinical observations that indicate suitability for
cuff deation, it should be noted that for almost a quarter of the
136 L.N. Pryor et al. / Australian Critical Care 29 (2016) 132137
cohort, strictly applying all of the 9 criteria would have unneces-
sarily delayed cuff deation trials. As such, all the clinical factors
considered key at the end of the decannulation pathway, that is,
prior to tube removal, may not be as important at the beginning.
There will always be some exceptions to any prognostic criteria, and
in those cases contextual issues, such as the individuals diagnos-
tic group, will be important to consider. For example, some patient
groups may never demonstrate cough adequacy (e.g. spinal cord
injury), or may never reach sufcient alertness (e.g. brain injury28 ),
yet may still tolerate cuff deation provided protective mecha-
nisms are intact. Therefore, requiring all patients to meet all of the
9 criteria may not necessarily be appropriate.
Rather than using the full set of 9 criteria, our data provides
empirical support for considering the medical and respiratory sta-
bility of the patient, as well as the ability to control oral secretions
prior to commencing cuff deation. These are consistent with
current clinical guidelines.19,20 However, within the current data
we have further qualied these, providing an objective measure
for the management of upper airway secretions, which had not
previously been explored. Although it is acknowledged that the
maximum of 24 ml within a 24 h period (i.e. average of 1 ml
per hour) followed within the current study may prove to be con-
servative for certain patient groups, in the current data set this
criteria assisted in correctly identifying the majority of patients
to be ready for continuous cuff deation. Only 5% of patients who
tolerated cuff deation failed to meet these 3 core criteria. With-
out exception, all had their tracheostomy inserted at the time of
head and neck surgery. This may suggest a greater tolerance for
larger volumes of upper airway secretions than other groups due
to clinically important differences in alertness, mobility and airway
clearance.
Of those who failed initial cuff deation, the demographics
revealed these individuals to be an older cohort, and they had
more upper airway secretions. Two-thirds were tracheostomised
for airway protection +/ impaired conscious state, and one-third
for head and neck surgery. Large above cuff secretions was the
only indicator for one patient who did not tolerate initial cuff
deation. They had a background of persistent bulbar dysfunction
leading to tracheostomy insertion in order to protect the airway.
The others, who also failed initial cuff deation, had large upper
airway secretions in combination with at least one additional fac-
tor with the potential to impact airway clearance. These included
altered pulmonary secretions, impaired alertness and/or a weak
cough.
This study used an objective measurement of upper airway sec-
retions as a surrogate for determining secretion management. This
could be a method for determining aspiration risk, as nearly all
the patients in this study were successful at their rst attempt
at cuff deation. Success may also have been enhanced by the
ability to remove secretions from above the inated cuff immedi-
ately prior to deation, minimising distress and discomfort through
reducing need for invasive suction, as well as reducing the risk
of pathogenic material from the upper airway entering the lower
airways.
An interpretation of these ndings is limited by the fact that
data was only recorded from a single site and only for the 24 h
immediately prior to initial cuff deation. Important recovery pat-
terns in the days/weeks preceding data collection are not captured.
As in any retrospective study the ndings depend on the accu-
racy of the documentation under review, and the small number
of unsuccessful patients limit the exploration of reasons for failure.
Future research should prospectively apply an agreed algorithm of
indicators to determine the clinical validity and explore the char-
acteristics most likely (and least likely) to impact the outcome.
Objective measures of pulmonary secretions, cough strength and
alertness would aid understanding.
4.1. Summary and conclusions
This study has reported on cuff deation and clinical decision
making processes for tracheostomised patients after weaning from
mechanical ventilation. Ninety-ve percent of patients successfully
tolerated continuous cuff deation at the rst attempt. The use
of the following 3 key indicators for readiness for cuff deation:
medical stability, respiratory stability and the ability to control sec-
retions as quantied by removal of 24 ml above cuff secretions
within a 24 h period, were supported. Our study describes the use
of a subglottic suctioning tracheostomy in monitoring the volume
of upper airway secretions. This may aid identication of aspirat-
ing patients and, as such, contribute to improved clinical decision
making.
Author contributions
All authors made substantial contributions to the conception,
design, analysis and interpretation of the data; and manuscript
preparation and revisions. All authors have approved the nal ver-
sion and are accountable for the accuracy and integrity of the
research.
Conict of interest
The authors declare no conicts of interest.
Acknowledgements
A grant from the Royal Adelaide Hospital Research Foundation
funded employment of a research assistant for data collection.
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