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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Speech Intelligibility as Assessed by Speech Intelligibility Test Score
Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
Time frame: 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).
Time frame: 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).
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the time of discharge, up to 4 months
Hospital Length of Stay
Hospital length of stay will be reported in days.
Time frame: At the time of discharge, up to 4 months
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