N/A
N=20
Early Speech With One-Way Speaking Valve in Tracheostomy Patients
Respiratory Failure · Speech · Aphonia
Bottom Line
View on ClinicalTrials.gov: NCT03008174 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Speech Intelligibility as Assessed by Speech Intelligibility Test Score — 25.71; 0 Percentage of intelligible words
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early one-way speaking valve (OWSV) assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Intelligibility as Assessed by Speech Intelligibility Test Score |
74.54; 35.97 | — |
| PRIMARY Speech Intelligibility as Assessed by Speech Intelligibility Test Score |
74.54; 35.97 | — |
| PRIMARY Speech Intelligibility as Assessed by Speech Intelligibility Test Score |
74.54; 35.97 | — |
| SECONDARY Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores |
55.0; 47.1 | — |
| SECONDARY Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores |
55.0; 47.1 | — |
| SECONDARY Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores |
55.0; 47.1 | — |
| SECONDARY Number of Participants With Bleeding |
0; 0 | — |
| SECONDARY Number of Participants With Bleeding |
0; 0 | — |
| SECONDARY Number of Participants With Bleeding |
0; 0 | — |
| SECONDARY Intensive Care Unit (ICU) Length of Stay |
51; 53.9 | — |
| SECONDARY Hospital Length of Stay |
69.7; 75.6 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03008174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.