ORIGINAL RESEARCH

Standard versus Accelerated Speaking Valve Placement after

Percutaneous Tracheostomy
A Randomized Controlled Feasibility Study
Kristen A. Martin1, Therese D. K. Cole1, Christine M. Percha2, Natsumi Asanuma3, Kathryn Mattare4, David N. Hager5,
Michael J. Brenner6,7, and Vinciya Pandian8
1
Department of Physical Medicine and Rehabilitation, Department of Anesthesiology and Critical Care Medicine, 4The Johns Hopkins
Hospital, Baltimore, Maryland; 2Department of Physical Medicine and Rehabilitation, Hartford Healthcare-Hartford Hospital, Hartford,
Connecticut; 3Department of Physical Medicine and Rehabilitation, Susan Mast ALS Foundation, Grand Rapids, Michigan; 5Department
of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; 6Department of Otolaryngology-Head & Neck Surgery,
University of Michigan Medical School, Ann Arbor, Michigan; and 7Global Tracheostomy Collaborative, Raleigh, North Carolina; and
8
Department of Nursing Faculty, Johns Hopkins School of Nursing, Baltimore, Maryland

ORCID ID: 0000-0002-2260-1080 (V.P.).

Abstract time to speaking valve placement was 22 (interquartile range [IQR],

Rationale: The feasibility of a large, multicenter, randomized
controlled trial comparing the risks and benefits of early-use
speaking valve after tracheostomy is not clear.
Objectives: To investigate the feasibility of accelerated (<24 h)
versus standard (>48 h) one-way speaking valve (“speaking valve”)
placement after percutaneous tracheostomy.
Methods: Twenty awake patients (Glasgow Coma Scale score
>9) were randomized to accelerated or standard timing of
speaking valve placement. Outcomes included patient
identification and recruitment, adherence to protocol-defined
time windows for valve placement, experimental separation in
time to first speaking valve placement between groups,
effectiveness of speech and swallowing (Sentence Intelligibility
Test score, patient-reported quality of life), and clinical outcomes
(safety events, speaking valve tolerance, decannulation, length of
stay, and mortality).
Results: Of 161 patients undergoing percutaneous tracheostomy,
20 of 36 meeting eligibility criteria were randomized. The median
21–23) hours in the accelerated arm versus 45.5 (IQR, 43–50) hours
for the standard arm. No aspiration, hypoxemia, or other safety
events occurred in either arm as a result of the speaking valve.
Sentence intelligibility test scores were not different between arms
but correlated with quality of life. After three sessions, patients in
the accelerated arm tolerated longer speaking valve trials than those
in the standard arm [median, 65 (IQR, 45–720) min vs. median, 15
(IQR, 3–20) min]. Seven patients in the accelerated arm were
decannulated before hospital discharge versus one patient in the
standard arm.
Conclusions: Speaking valve placement within 24 hours of
percutaneous tracheostomy is feasible. A multicenter randomized
controlled trial should be conducted to evaluate the safety of this
strategy and compare important clinical outcomes, including time
to speech and swallow recovery after tracheostomy.
Clinical trial registered with ClinicalTrials.gov (NCT03008174).
Keywords: tracheostomy; quality of life; communication;
one-way speaking valve; feasibility

(Received in original form October 13, 2020; accepted in final form February 23, 2021)
Supported by National Institutes of Health R01 5-R017433 (V.P.), on laryngotracheal injury and rehabilitation after translaryngeal intubation in
intensive care unit settings.
Correspondence and requests for reprints should be addressed to Vinciya Pandian, Ph.D., M.B.A., M.S.N., R.N., A.C.N.P.-B.C., F.A.A.N.P.,
F.A.A.N., F.R.C.S.I., Department of Nursing Faculty, Johns Hopkins School of Nursing, 525 N. Wolfe Street, Baltimore, MD 21205.
E-mail: vpandia1@jhu.edu.
This article has an online supplement, which is accessible from this issue’s table of contents at www.atsjournals.org.
Ann Am Thorac Soc Vol 18, No 10, pp 1693–1701, Oct 2021
Copyright © 2021 by the American Thoracic Society
DOI: 10.1513/AnnalsATS.202010-1282OC
Internet address: www:atsjournals:org

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 ORIGINAL RESEARCH

In the United States, assessment of patient
candidacy for one-way speaking valve
(hereafter “speaking valve;” Figure 1) is
routinely deferred until 48 hours after
percutaneous tracheostomy (1, 2). Although
some speech–language pathologists (SLPs) in
Europe and Australia introduce speaking
valves within 4 hours of the procedure (3), data
supporting the clinical benefits and safety of
this approach are from observational studies
with limited generalizability. Earlier speaking
valve placement may expedite speech
rehabilitation, thereby improving
communication and quality of life (4–6). In
addition, speaking valve use may improve
end-expiratory lung volume, alveolar
recruitment, and diaphragm mobility—all
factors that can facilitate liberation from
mechanical ventilation (7–11). However, the
risks of earlier speaking valve placement
require further assessment. Indeed, early
placement could potentially trigger untoward
outcomes because of immature tracheostomy
tracts. Examples include subcutaneous air,
pneumomediastinum, pneumothorax, and
accidental decannulation.
Although a large, multicenter,
randomized controlled trial comparing the
risks and benefits of accelerated speaking valve
placement after tracheostomy would provide
more meaningful guidance than the existing
observational studies, the feasibility of such a
trial is not clear. Potential barriers to
completion include 1) the identification and
recruitment of participants, 2) the ability to
achieve meaningful temporal separation
between accelerated valve placement versus
that in a standard care control group, 3)
uncertain clinician acceptance of accelerated
speaking valve use, and 4) as yet
undemonstrated ability of available
instruments to detect speech rehabilitation
endpoints in this novel study population. We
therefore conducted a prospective
randomized controlled feasibility trial to
investigate these issues and to identify other
methodological, safety, and operational
factors that would inform the design of a
larger study.
Methods
This trial was approved by the Johns Hopkins
University Institutional Review Board
(protocol number IRB00080981) and is
registered at ClinicalTrials.gov
(NCT03008174).
Study Design
In this prospective randomized controlled
trial, the first placement of a speaking valve
between 12 and 24 hours after percutaneous
tracheostomy (intervention group;
accelerated arm) is compared with first
placement between 48 and 60 hours after
percutaneous tracheostomy (control group;
standard care arm). Enrolled participants
were randomly assigned to each group in a
1:1 ratio.
Participants
All adult patients admitted to any of three
participating intensive care units (ICUs) at
Johns Hopkins Hospital and undergoing
percutaneous tracheostomy were screened for
enrollment. To be included in the trial,
patients had to exhibit an adequate level of
consciousness and stable mental status
(Glasgow Coma Scale [GCS] score > 9,
Confusion Assessment Method-ICU
[CAM-ICU] negative, and Richmond
Agitation–Sedation Scale [RASS] of 21 to 11)
and had to speak English (Table E1 in the
online supplement). Patients were excluded if
they exhibited upper airway obstruction, had a
diagnosis of a difficult airway per anesthesia
assessment, or had complications from
tracheostomy (i.e., bleeding requiring
transfusion, air leak around tracheostomy cuff
compromising ventilation, subcutaneous
emphysema, or pneumothorax).
Randomization and Blinding
Participants were randomized to accelerated
speaking valve placement versus standard
timing using the RAND (randomization)
function in Microsoft Excel software
(Microsoft Office Systems). This assignment
was stored in a password-protected file. After
each patient’s consent, the speech–language
pathology (SLP) team would be notified of
whether the patient had been randomized to
the accelerated or standard arm of the study.
Given the intervention, group assignment was
not blinded, with the exception of an
assessment of speech intelligibility, which is
discussed below.
Intervention
Participants in the accelerated speaking valve
group were assessed by SLP for valve
placement between 12 and 24 hours after
tracheostomy. Provided there were no
contraindications at the time of assessment, a
speaking valve was placed, and performance
metrics (see below) were assessed (session 1;
Figure 2). The standard care group was only
assessed for quality of life during session 1,
with no speaking valve placement. Between 48
and 60 hours after tracheostomy, both study
groups were assessed for speaking valve
placement and performance metrics (session
2). A third assessment was conducted 2 weeks
after tracheostomy (session 3). For all sessions,
speaking valve trials required coordination
between SLPs, respiratory care practitioners
(RCPs), bedside nurses, and provider teams.
This coordination ensured adequate
monitoring and safety during the trials and
optimization of ventilator settings for patient
comfort (online supplement, Table E2). For

Author Contributions: K.A.M.: data acquisition, interpretation of the data, drafting of the manuscript, final approval of the version to be published,
and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are
appropriately investigated and resolved. T.D.K.C. and C.M.P.: conception and design of study, data acquisition, critical revision of the manuscript
for important intellectual content, final approval of the version to be published, and agreement to be accountable for all aspects of the work in
ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. N.A.: data
acquisition, critical revision of the manuscript for important intellectual content, final approval of the version to be published, and agreement to be
accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately
investigated and resolved. K.M., D.N.H., and M.J.B.: interpretation of the data, critical revision of the manuscript for important intellectual content,
final approval of the version to be published, and agreement to be accountable for all aspects of the work in ensuring that questions related to the
accuracy or integrity of any part of the work are appropriately investigated and resolved. V.P.: conception and design of the study, data analysis,
interpretation of the data, drafting the manuscript, critical revision of the manuscript for important intellectual content, final approval of the version to
be published, and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part
of the work are appropriately investigated and resolved

1694 AnnalsATS Volume 18 Number 10 | October 2021

 ORIGINAL RESEARCH

Exhalation

Vocal Vocal
cords cords

One-Way One-Way
Speaking Valve Speaking Valve

Inhalation

From the lungs

To the lungs

Inhalation Exhalation
Figure 1. Anatomical depiction of the use of one-way speaking valve. This figure represents two cross-sectional views of the upper airways with a
tracheostomy tube in situ. In addition, a one-way speaking valve is present on the tracheostomy tube. In the panel on the left, the picture depicts
airflow during inhalation and how the air is directed to the lungs. In the panel on the right, the picture depicts airflow during exhalation and how the air
is directed to the upper airways (around the tracheostomy tube) through the vocal cords to the nasopharynx and oropharynx. Illustrations: Tim
Phelps 2019 JHU AAM, Department of Art as Applied to Medicine, The Johns Hopkins University School of Medicine.

mechanically ventilated patients, in-line Passy
Muir Speaking Valves (PMV 007, Aqua Color;
Passy Muir, Inc.) were used; for nonventilated
patients, Passy Muir Speaking Valves (PMV
2001, Purple Color; Passy Muir, Inc.) were
used (2, 12–18).
Outcomes
As a feasibility trial, the key outcomes of
interest were pace of participant recruitment
and adherence to the protocol, which included
achieving adequate temporal separation in
initial speaking valve use between patients in
accelerated versus standard groups. A
separation of 24 hours between groups was
sought. Speech-related outcomes included
performance on the Sentence Intelligibility
Test (SIT), which recorded participant speech
during speaking trials (19). Recordings were
subsequently scored by experienced SLPs
blinded to study group assignment. The SIT
uses a 1 to 100 scale, with higher scores
indicating more intelligible speech. Speech
quality was also evaluated, but in this case,
listeners were not blinded. Other speech-
related outcomes measured included speaking
valve tolerance (minutes of speaking valve use
without distress; parameters detailed in online
supplement) and independence (need for SLP,
RCP, nurse, or family supervision during
speaking valve use; Table 1).
Other outcomes of interest included
Quality of Life (QOL) of Mechanically
Ventilated Patients (QOL-MV; score 1 to 120;
higher scores indicate better QOL) score,
patient-reported satisfaction, progression of
swallow (based on a modified barium swallow
study or fiber optic endoscopic evaluation),
time to decannulation, ICU and hospital
lengths of stay, and mortality. We monitored
several safety endpoints, including bleeding,
subcutaneous air, pneumothorax, accidental
decannulation, tracheal–esophageal fistula,
inadvertent occlusion of tracheostomy,
abnormalities of gas exchange, and any
changes in status that triggered rapid response
events (see online supplement).
Statistical Methods
All analyses adhered to an intention-to-treat
approach. Descriptive statistics for continuous
variables are presented as medians with
interquartile range (IQR), and frequencies and
percentages are presented for categorical
variables. As a feasibility trial, sample size
calculations were deferred; however, a
minimum enrollment of 10 patients to each
study arm was planned to identify barriers to
implementing the protocol. Between group
comparisons were assessed using the

Martin, Cole, Percha, et al.: Early Use of One-Way Speaking Valve 1695
 ORIGINAL RESEARCH

Wilcoxon rank-sum test or Fisher’s exact test

Total Patients Screened as appropriate. The proportion of patients who
N=193 met feasibility targets are described with
percentages. For exploratory purposes, a
multivariate, stepwise, backward linear
regression analysis was conducted to identify
potential predictors of SIT and QOL,
Percutaneous controlling for potential confounding factors
Open Tracheostomy
(n=31)
Tracheostomy such as age, sex, race, intubation duration,
(n=161) indications for admission, and illness severity.

Did not meet eligibility criteria: Results

• GCS < 9 = 119
• Difficult Airway = 4 Recruited Population
• Clinically unstable = 2 Between February 2016 and November 2019,
• Declined Participation = 16 161 patients underwent percutaneous
tracheostomy inthe participating ICUs. Thirty-
six met eligibility criteria, and the 20 (55.5%)
Met Eligibility Criteria patients who provided consent to participate in
and the study were randomized to accelerated
Provided Consent speaking valve (n = 10) or standard care (n = 10)
(Figure 2). Sixteen were invited to participate in
the study but did not provide consent. Patients
Randomized who failed to meet enrollment criteria included
patients with low GCS score of less than 9 (n =
Accelerated Group Standard Group 119),difficultairwayanatomy(n=4),orclinical
(n=10) (n=10) instability (n = 2). The median age of enrolled
participants was 45 (IQR, 35–67.5) years, and
55% were women. The median baseline
Session 1 Session 1 Sequential Organ Failure Assessment score for
(n = 10) (n = 10) all participants was 6 (IQR, 5–6.5) and did not
differ between randomization groups. Other
No SLP Evaluation or
SLP Evaluation + baseline characteristics were also similar
OWSV Trial or
OWSV Trial + between groups (Tables 1 and E3).
SIT assessment;
QOL and SIT assessments
Only QOL assessment
Protocol Implementation
All participants underwent speaking valve
Session 2 Session 2 evaluation according to the protocol (e.g.,
(n = 10) (n = 10) <24 h for the accelerated group and >48 h for
standard care group) at session 1, although one
SLP Evaluation + SLP Evaluation + patient in the accelerated group, discussed
OWSV Trial + OWSV Trial + subsequently, did not pass the 1-minute finger
QOL and SIT assessments QOL and SIT assessments
occlusiontest because of laryngeal edema, and a
speaking valve was not attempted. The speech
rehabilitation required a concerted effort by
Session 3 Session 3 nursing staff, SLPs, and RCPs to align
(n = 7) (n = 6) schedules. All participants had session 2 speech
rehabilitation assessments, but seven
SLP Evaluation + SLP Evaluation + participants (three in the accelerated group and
OWSV Trial + OWSV Trial + four in the standard care group) did not
QOL and SIT assessments QOL and SIT assessments complete session 3. Of these seven individuals,
four died, two were discharged from the
Figure 2. Study protocol. The study protocol showing the randomization into two groups and the institution, and one developed neurocognitive
follow-up sessions are portrayed in this picture. The assessments and interventions provided impairment. All clinical assessments, including
during each session are listed. In addition, data regarding the number of patients who did not swallow function, time to decannulation, ICU
meet the eligibility criteria are presented. GCS = Glasgow Coma Scale; OWSV = one-way and hospital lengths of stay, and mortality, were
speaking valve; QOL = quality of life; SIT = Sentence Intelligibility Test; SLP = speech–language
able to be collected as per protocol.
pathologist.

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Table 1. Baseline data comparing standard and accelerated groups

Standard Accelerated
Patient characteristics (n = 10) (n = 10) P Value

Age, yr 48 (38–64) 40 (35–74) 0.78

Sex Female 5 (50) 6 (60) 0.65
Male 5 (50) 4 (40)
Race/ethnicity White 3 (30) 6 (60) 0.26
African American 6 (60) 3 (30)
Hispanic 1 (10) 0 (0)
Other 0 (0) 1 (10)
Indication for admission Pulmonary 5 (50) 7 (70) 0.27
Neurological 5 (50) 2 (20)
Cardiac 0 (0) 1 (10)
Intubation duration (days) 9.5 (7–16) 16.5 (9–19) 0.25
Indication for tracheostomy Chronic ventilator dependence 10 (100) 10 (100)
Initial tracheostomy tube size 6.0 cuffed 7 (70) 9 (90) 0.26
8.0 cuffed 3 (30) 1 (10)
Tracheal suctioning requirement
Suctioning frequency (every 3 h) 2 (2–4) 2 (1–3) 0.68
Amount Small 3 (30) 4 (40) 0.79
Moderate 5 (50) 5 (50)
Copious 2 (20) 1 (10)
Consistency Thin 4 (40) 1 (10) 0.12
Thick 6 (60) 9 (90)
Color Clear 1 (10) 0 (0) 0.45
Creamy 0 (0) 1 (10)
Blood-tinged 4 (40) 4 (40)
Tan 2 (20) 4 (40)
White 3 (30) 1 (10)
Sequential Organ Failure Assessment score 6 (5–6) 6 (4–7) 0.77

Age, days intubated, and suction frequency are reported in median (interquartile range); remaining variables are reported in frequencies
(percentages).

Speech Rehabilitation Assessments
Tolerance to speaking valve and
independence with speaking valve. Median
time to speaking valve placement was 22 (IQR,
21–23) hours in the accelerated arm versus
45.5 (IQR, 43–50) hours in the standard arm
from the time of tracheostomy. Participants in
the accelerated arm tolerated the speaking
valve for a median of 10 (IQR, 5–35) minutes
during session 1 (Table 2); participants in the
standard arm did not receive a speaking valve
evaluation during session 1 per protocol.
During session 2, the accelerated group
tolerated the speaking valve for a median of 7.5
(IQR, 5–60) minutes versus 20 (IQR, 7–35)
minutes in the standard group (P = 0.84).
By session 3, the accelerated group
tolerated the speaking valve for a significantly
longer duration (P = 0.03) (65 min; IQR,
45–720 min) compared with the standard
group (15 min; IQR, 3–20 min). One patient in
the accelerated group did not tolerate cuff
deflation at any of the three sessions (Table E4)
and was, therefore, given a duration of 0
minutes for all data analyses. Upon further
evaluation by an otolaryngologist using a
flexible laryngoscopy after session 3, the
patient was found to have upper airway edema.
During session 1 (intervention group) and
session 2 (both groups), most participants
required supervision from a SLP, nurse, or
RCP to use their speaking valves (Table 3). By
the end of session 3, three (43%) of the
accelerated arm participants were using their
speaking valves independently or with family.
In contrast, only one participant (16.7%) in the
standard arm was a candidate for independent
use of the speaking valve.
Speech intelligibility, voice quality,
QOL, and satisfaction. All instruments were
successfully administered to all study
participants. The median session 1 SIT score
for the accelerated group was 9.4 (IQR,
0–53.9). The median session 1 SIT score for the
standard care groups was 0, as they did not
receive a speaking valve per protocol. At
subsequent sessions, SIT scores did not differ
between arms. Voice quality was also similar
between experimental arms at sessions 2 and 3,
although there was significant heterogeneity in
voice quality within groups (Table 2). Patient-
reported QOL did not differ between groups
(session 1 = 40.6 [IQR, 34.8–51.5], session 2 =
50.1 [IQR, 40.9–70.9], and session 3 = 57.6
[IQR, 36.3–73.7]), although SIT scores
correlated with participant perception of
QOL; after controlling for session and
experimental arm, each 1-point increase in SIT
score corresponded with a 0.20-point increase
in on the QOL-MV (P = 0.03).
Swallowing, decannulation, and length
of stay. All participants in our study were nil
per os at sessions 1 and 2. By session 3, two in
each group were able to swallow orally (Table
E3). Seven participants in the accelerated arm
and one in the standard care arm were
decannulated while still in the hospital (P =
0.006). However, the median time to
decannulation, ICU length of stay, and
hospital length of stay did not differ between
groups (Table E5).
Safety and Mortality Outcomes
Prospective standardized safety monitoring
protocols revealed no adverse events, near
misses, or mortality attributable to speaking
valve trials. However, subcutaneous air was
noted in one participant in the accelerated arm
during session 1 and in another participant in
the standard arm during session 2. In each case,
a retrospective focused review of chest
radiographs by the physicians revealed that the
subcutaneous air was visible after

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Table 2. Comparison of clinical outcomes between standard and accelerated groups at each session

Clinical outcomes Session Number Standard Accelerated P Value

Speech Intelligibility Test score, median (IQR) 1 0 9.4 (0–53.9) 0.03

2 32 (0–58.7) 4.2 (0–63.2) 0.09
3 24.4 (0–78.9) 73.6 (56.8–92.3) 0.16
Voice quality, n (%)
Hoarse 1 — 1 (10) —
2 4 (40) 3 (30) 0.79
3 1 (17) 2 (33) 0.35
Rough 1 — 0 —
2 0 0 0.79
3 1 (17) 0 0.35
Strained 1 — 2 (20) —
2 3 (30) 2 (20) 0.79
3 0 1 (17) 0.35
Breathy 1 — 2 (20) —
2 2 (20) 2 (20) 0.79
3 1 (17) 2 (33) 0.35
Dysphonic 1 — 2 (20) —
2 0 1 (10) 0.79
3 1 (17) 0 0.35
Aphonic 1 — 3 (30) —
2 1 (10) 2 (20) 0.79
3 2 (33) 0 0.35
Duration of speaking valve tolerance, median (IQR), min 1 — 10 (5–35) —
2 20 (7–35) 7.5 (5–60) 0.84
3 15 (3–20) 65 (45–720) 0.03
Independence with speaking valve, n (%)
With speech–language pathologist only 1 — 7 (70) —
2 6 (60) 6 (60) 1.0
3 3 (50) 3 (42.9) 0.61
Trained staff 1 — 2 (20) —
2 4 (40) 3 (30) 1.0
3 2 (33.3) 1 (14.3) 0.61
Independent or with family 1 — 1 (10) —
2 0 1 (10) 1.0
3 1 (16.7) 3 (42.9) 0.61
QOL-MV score, median (IQR) 1 46.9 (35.4–51.5) 40.6 (34.8–51.5) 0.80
2 43 (40.3–51.4) 50.1 (40.9–70.9) 0.36
3 43 (33.9–59.8) 57.6 (36.3–73.7) 0.76
Reported satisfaction, n (%) 1 — 7 (70) —
2 7 (70) 7 (70) 1.0
3 3 (50) 6 (85.7) 0.22

Definition of abbreviations: IQR = interquartile range; QOL-MV = Quality of Life in Mechanically Ventilated Patients questionnaire.

tracheostomy procedure but before speaking
valve placement. Both participants were
observed without any additional interventions.
Other postoperative complications were minor
(Table E5). Two deaths occurred in each study
group (Figure E3); all were attributed to
progression of underlying disease with
transitions to comfort measures (see online
supplement). Before death, one participant
noted the speaking valve permitted her to say “I
love you” to family members.
Discussion
We randomized 20 patients to accelerated
speaking valve trials versus standard care after
percutaneous tracheostomy to assess protocol
feasibility, with the long-term goal of
conducting a larger multicenter study to assess
efficacy and safety of early speaking valve
placement. In our study, a minority of patients
undergoing percutaneous tracheostomy
qualified for enrollment, with most patients
being excluded because of a low GCS score.
However, among those that qualified for
enrollment, more than half were willing to
participate, and the majority of enrolled
participants were able to complete the
protocol. Those not completing the protocol
were either discharged before the final
assessment or experienced progression of
disease that prohibited further participation.
In no case was disease progression believed to
be related to the timing of the first use of
speaking valve. Of note, it took 3 years to enroll
the planned 20 patients. These findings suggest
a larger study of similar patients is feasible but
would require a multicenter, collaborative
approach. Modifications to the inclusion and
exclusion criteria could mitigate some of the
challenges of enrollment.
Recruitment and Retention
Recruitment was primarily limited by
stringent eligibility criteria designed to
facilitate effective participation in speech
assessments and mitigate the risk of adverse
events. Most subjects (n = 119) were excluded
because of alterations in mental status.
However, although a person with a higher
GCS score who is alert and calm may be more
likely to effectively participate in assessments
of speech intelligibility, a low GCS score does

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Table 3. Levels of independence

Does Not
Tolerate Cognitive Physical
Cuff Deflation Lack of Impairment Impairment
(Change in Vital Tolerance Requires Affecting Ability Affecting
Signs/Impaired Aphonic Requires to In-Line Frequent to Successfully Ability to
Airway Vocal Ventilator Speaking Tracheal or Seek Use Call
Tier Level of Independence Clearance) Quality Adjustments Valve Oral Suctioning Attention Bell for Help

I Supervision required by Y Y Y Y Y Y Y
speech–language
pathologist
II Supervision required by N N Y Y Y Y Y
respiratory care
practitioners/
physiotherapists
III Supervision required by N N N N Y Y Y
trained staff (nurses and
occupational/physical
therapists)
IV Independent or assistance N N N N N N N
sought from trained family
member/caregiver

Definition of abbreviations: N = no; Y = yes.

not necessarily increase the risk of early
placement of a speaking valve. Indeed, an
argument can be made that the ability to
communicate earlier may decrease agitation
and even delirium (20). A much smaller
number of patients were excluded because of
the presence of a difficult airway, clinical
instability, or ventilator requirements not
conducive to speaking valve placement. We
also excluded patients who had undergone an
open (surgical) tracheostomy, as there is a
perception that these patients may be at higher
risk for adverse events such as bleeding or
subcutaneous emphysema. However, it is not
clear that these concerns are valid, an issue that
warrants further investigation. Lack of
readiness to consent (n = 16) was another
barrier to enrollment for several otherwise
eligible patients. Having a discussion of
opportunity for enrollment in this trial before
the tracheostomy—rather than shortly after,
when many patients and families are
preoccupied with tracheotomy care—may
have increased participation, given the narrow
window for enrollment into the study. One
barrier we did not encounter was resistance
from the clinical team to the accelerated
placement of a speaking valve. We also did not
encounter instances in which patients in the
accelerated group requested a delay in
speaking valve placement, but two patients in
the standard group sought speaking valve
placement before 48 hours.
Protocol Implementation
Timing of speaking valve. All
participants randomized to accelerated
speaking valve placement underwent session 1
speaking valve evaluation between 12 and 24
hours after tracheostomy. One patient could
not tolerate a 1-minute finger occlusion test,
and a speaking valve was not attempted. The
underlying etiology of upper airway edema
was not established until weeks later, whereas
upper airway assessment using endoscopy at
the time of failed finger occlusion test could
have excluded this patient from the study. For
this reason, future studies may consider an
upper airway endoscopy when a SLP
evaluation is abnormal. The 12–24-hour
interval after tracheostomy presented no
implementation challenges for the remaining
nine patients. Although a few observational
studies have reported successful placement of
speaking valves within 4 hours of
tracheostomy (21), such early speaking valve
placement would likely increase the hurdles to
achieving adequate recruitment, particularly if
the GCS and RASS thresholds used for this
feasibility study were unchanged in future
studies, as residual sedation is most likely to
affect these measures in the initial hours after
surgery. Importantly, our window of 12–24
hours for the accelerated group was late
enough to identify 36 candidates who met GCS
and RASS thresholds yet early enough to give
us clear temporal separation between groups.
Assessment of Speech Rehabilitation
The SIT. The SIT was administered
successfully to all patients, but it may be subject
to floor effects, lacking discriminative power in
patients who have a meaningful but limited
ability to communicate with a speaking valve.
For example, anecdotally, several nurses
reported instances in which patients
demonstrated improved communication with
clinicians and family after speaking valve
placement, even when the SIT scores were
sufficiently low to suggest no improvement.
This finding suggests a need for instruments
that are more sensitive for capturing patient
communication. Therefore, tools that assess
verbal communication not discernible using
the SIT repository may be considered in future
studies to capture organized thinking. Despite
this limitation, the computerized assessment
of intelligibility of speech using the SIT allows
for more objectivity than face-to-face
judgments of comprehensibility. The SIT
computer analysis is not influenced by
contextual factors and provides a nonbiased
assessment of speech intelligibility; however,
the SIT relies on preset words and sentences
that may not be applicable or of interest to the
patients, thereby making the tool potentially
restrictive.
The QOL-MV. The QOL-MV was
successfully administered to all study
participants, but scores did not differ between
study groups. Although the QOL-MOV is not

Martin, Cole, Percha, et al.: Early Use of One-Way Speaking Valve 1699
 ORIGINAL RESEARCH

specific to communication and speaking, it is
valid for ventilator-dependent populations.
The caveat with QOL-MOV is that its domains
that are not related to speech, such as overall
comfort, sleep, and pain, may be affected by the
severity of illness, diagnosis, and medications,
thereby dampening speech-related signals. A
similar limitation has been noted when using
the EuroQol-5D to assess speech-related QOL
(22). For these reasons, future studies should
consider using instruments that specifically
measure patient-reported quality of life
relevant to voice, such as the voice-related
QOL score (23).
Other assessments of rehabilitation. The
other assessments of speech and airway
rehabilitation, specifically duration of speaking
valve tolerance, independence with valve in
place, progression of swallow, and time to
decannulation, were all straightforward to
monitor and useful outcomes to include in
subsequent larger trials.
Safety and Clinical Outcomes
Although this trial was not designed or
powered to measure safety, all patients were
carefully monitored throughout the study
period to detect complications, medical errors,
or other adverse events that would inform a
larger trial design or require specific
monitoring in that setting. The only safety
events we identified were a case of airway
edema that precluded speaking valve
placement (not known before randomization)
and two occurrences of subcutaneous
emphysema. These safety-related data suggest
that an endoscopic evaluation may be
warranted if patients fail speaking valve trial
after meeting clinical readiness criteria. The
presence of subcutaneous emphysema was
first detected after the speaking valve
evaluation, but a review of the chest X-ray
shortly after the tracheostomy demonstrated
that the air was present before the speaking
valve evaluation. Future study designs should
include careful inspection of chest X-ray
subjects to avoid enrollment of subjects with
subcutaneous emphysema.
Participants in our accelerated arm had a
longer duration ofspeaking valve use at session
3, with the caveat of small sample size and wide
IQR. Three participants in the accelerated arm
were decannulated compared with only one in
the standard arm. Although this observation is
also limited by the sample size, the structured
approach to capping and decannulating used
at our institution gives us confidence all
patients were assessed for decannulation in a
timely fashion (24). Larger studies should
follow a similar strategy.
Limitations
There are important limitations of our study
protocol. First, members of the research and
clinical teams were not blinded, with the
exception of SLP assessment of speech
intelligibility. Although creative approaches
could be considered in future studies, such as
covering the speaking valves or using sham
valves, this would significantly misinform
providers on important clinical endpoints
such as the potential readiness of participants
for ventilator weaning. Second, there was likely
a practice effect in the accelerated group
relative to the standard group (25, 26). The
accelerated group’s first evaluation involved
speaking valve placement, whereas the
standard group did not have a speaking valve
placed until the second visit. Although the
experimental design allowed for assessment of
speaking valve tolerance at matched time
points, an alternative design may have inserted
an additional evaluation or practice session for
the standard group to allow for a more
balanced comparison between groups at the
third evaluation time point. Third, our
experience and use of the protocols are from a
single institution, and it is unknown whether
the implementations of protocols would be
similarly successful elsewhere.
Conclusions
Speaking valve placement within 24 hours
after percutaneous tracheostomy appears
feasible in patients who meet clinical readiness
criteria. Pilot data indicate modifiable barriers
to consent, possible floor effect of SIT, and
utility of other metrics of speech rehabilitation.
The data also reveal potential limitations of
our measure of QOL, the need for additional
tools to capture organized thinking, and new
triggers for safety assessments of airway edema
and subcutaneous air. With these changes, a
large-scale multicenter trial of accelerated
versus standard timing of first speaking valve
use is likely to provide a valuable comparison
of meaningful outcomes in this population. 䊏
Author disclosures are available with the text
of this article at www.atsjournals.org.
Acknowledgment: The authors thank their
fellow speech–language pathologists, RCPs,
nurses, physicians, and advanced practice
providers. Speech–language pathologists who
assisted with this project include Colleen
McElroy, Gabrielle Miller, Nicole Langton,
Kathleen Holden, and Christine Smith in
recruiting, administering assessments, and
grading Sentence Intelligibility Tests. RCPs were
instrumental in informing the authors of potential
participants and assisting with the completion of
in-line speaking valve assessments while the
patients were on ventilators. Nurses, physicians,
and advanced practice providers offered their
interdisciplinary expert opinions as needed. The
authors also thank their participants, who—while
processing and dealing with critical illness—
were eager and willing to participate in their
research. They also thank Martin Blair for helping
with editorial support.

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