Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Patients with tracheostomy who are on and off of mechanical ventilation initially lose the ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring speech in these patients. Patients with tracheostomy who experience loss of speech report frustration and feelings of confinement from patients' communication impairment, therefore investigators would like to restore speech in these patients as soon as it is safe to do so. However, there is currently little known in the literature about the timing of the use of OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test clinical trial pilot study to investigate the safety of early use of OWSV in patients undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit from the early use of OWSV and to determine the effects of early use of OWSV on speech and clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will be screened, and patients meeting screening criteria will be randomized into intervention and control groups. The intervention group will receive early speech-language pathology (SLP) evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control group will receive standard SLP evaluation and OWSV trial at 48-60 hours following tracheostomy procedure. Intervention and control groups will been compared on speech and clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test at 48-60 hours following tracheostomy and characteristics of patients who successfully tolerate early OWSV use will be identified.

Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure. Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.

Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.

The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure

At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure

Inclusion Criteria: Patient who received a percutaneous tracheostomy Glasgow Coma Scale score ≥9 Confusion Assessment Method -ICU (CAM-ICU): negative Richmond Agitation Sedation Scale (RASS): -1 to +1 Able to understand English Exclusion Criteria: Open tracheostomy Laryngectomy Presently using OWSV or capped trach Foam-filled cuffed tracheostomy tube Presence of known severe airway obstruction Presence of post-operative bleeding requiring transfusion or packing Presence of air-leak around the cuff resulting in respiratory decompensation

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