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).