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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03008174
The ClinicalTrials.gov registry entry for NCT03008174 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Early one-way speaking valve (OWSV) assessment is the first listed.
NCT03008174 reports 0 study locations.
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.
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