Standard versus Accelerated Speaking Valve Placement after Percutaneous Tracheostomy: A Randomized Controlled Feasibility Study

Kristen A Martin, Therese D K Cole, Christine M Percha, Natsumi Asanuma, Kathryn Mattare, David N Hager, Michael J Brenner, Vinciya Pandian, Kristen A Martin, Therese D K Cole, Christine M Percha, Natsumi Asanuma, Kathryn Mattare, David N Hager, Michael J Brenner, Vinciya Pandian

Abstract

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 time to speaking valve placement was 22 (interquartile range [IQR], 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: communication; feasibility; one-way speaking valve; quality of life; tracheostomy.

Figures

Figure 1.
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.
Figure 2.
Figure 2.
Study protocol. The study protocol showing the randomization into two groups and the follow-up sessions are portrayed in this picture. The assessments and interventions provided during each session are listed. In addition, data regarding the number of patients who did not meet the eligibility criteria are presented. GCS = Glasgow Coma Scale; OWSV = one-way speaking valve; QOL = quality of life; SIT = Sentence Intelligibility Test; SLP = speech–language pathologist.

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Source: PubMed

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