Ann Am Thorac Soc. 2021 Mar 24. doi: 10.1513/AnnalsATS.202010-1282OC. Online ahead of print.
RATIONALE: Feasibility of a large, multi-center, randomized controlled trial (RCT) comparing the risks and benefits of early use speaking valve following tracheostomy is not clear.
OBJECTIVE: To investigate the feasibility of accelerated (≤ 24 hours) versus standard (≥ 48 hours) one-way speaking valve ("speaking valve") placement after percutaneous tracheostomy.
METHOD: 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 [SIT] score, patient-reported quality of life [QOL]), and clinical outcomes (safety events, speaking valve tolerance, decannulation, length of stay, 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 (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. SIT scores were not different between arms but correlated with QOL. After 3 sessions, patients in the accelerated arm tolerated longer speaking valve trials than the standard arm [Median (IQR): 65 (45 - 720) vs. 15 (3-20) minutes]. 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, control trial should be conducted to evaluate the safety of this strategy and compare important clinical outcomes, including time to speech and swallow recovery following tracheostomy. Clinical trial registered with ClinicalTrials.gov (NCT03008174).