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NCT03008174 · ClinicalTrials.gov registry record · NA
Early Speech With One-Way Speaking Valve in Tracheostomy Patients
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03008174: Completed NA study, sponsored by Johns Hopkins University.
NCT03008174 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03008174, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
Interventions
- OTHER Early one-way speaking valve (OWSV) assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-02-05 |
| Est. Completion | 2019-12-05 |
| Phase | NA |
What the finished NCT03008174 record still lists
NCT03008174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Early one-way speaking valve (OWSV) assessment is the first listed.
NCT03008174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03008174 about?
NCT03008174 is a clinical study titled "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 ...
What is the current status of trial NCT03008174?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2016-02-05. Estimated completion is 2019-12-05.
What interventions are being tested in trial NCT03008174?
The interventions under investigation include: Early one-way speaking valve (OWSV) assessment (OTHER).
Who is sponsoring clinical trial NCT03008174?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03008174's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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