Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Study Overview
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Brief Summary
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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.

Official Title
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Early Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study

Conditions
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Respiratory Failure, Speech, Aphonia

Intervention / Treatment
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* Other: Early one-way speaking valve (OWSV) assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: Early one-way speaking valve (OWSV) assessment<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Intelligibility as Assessed by Speech Intelligibility Test Score | Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible). | Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period) | 
| Speech Intelligibility as Assessed by Speech Intelligibility Test Score | Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible). | Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period) | 
| Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 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. | Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period) | 
| Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 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 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period) | 
| Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 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) | 
| Number of Participants With Bleeding | Bleeding will be reported as present or absent. | At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure | 
| Number of Participants With Bleeding | Bleeding will be reported as present or absent. | At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure | 
| Number of Participants With Bleeding | Bleeding will be reported as present or absent. | At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure | 
| Intensive Care Unit (ICU) Length of Stay | ICU length of stay will be reported in days. | At the time of discharge, up to 4 months | 
| Hospital Length of Stay | Hospital length of stay will be reported in days. | At the time of discharge, up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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speech, tracheostomy, quality of life, speaking valve, mechanically ventilated patients