Evaluation of a Tracheostomy Tube That Enables Communication
Public ClinicalTrials.gov record NCT02018562. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Evaluation of a Tracheostomy Tube That Enables Communication in Ventilator Dependent Patients - A Pilot Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Verbal communication is vital to critically ill mechanically ventilated patient's quality of life (Hess, 2005). Patients who have a tracheostomy tube may be able to communicate using a speaking valve, however, some patients may not be able to tolerate cuff deflation for use of speaking valve. There are talking tracheostomy tubes that do not require cuff deflation to facilitate speech in this population. Unfortunately, not all candidates are offered these options due to lack of awareness. Recently, at our institution, there has been an increase in the use of these tubes to facilitate speech. One of the talking tracheotomy tubes that has proven to be effective is the Portex Blueline Ultra Suctionaid (BLUSA). In 2010, we conducted a retrospective review of 4 cases and found that BLUSA tracheostomy helped facilitate communication in this unique population (IRB #: NA\_00041547). We would now like to formally conduct a prospective pilot study to evaluate the feasibility of measuring outcomes of patients with a BLUSA using a pretest-posttest research design. Communication empowers patients and allows healthcare staff to obtain a more accurate assessment of patients' condition and tailor care accordingly. Identifying the predictors of speech intelligibility and the impact of BLUSA on quality of life will promote communication between patients and healthcare providers. Study Hypothesis: Determine the impact of a talking tracheostomy tube on quality of life in patients requiring prolonged mechanical ventilation in the hospital.
Study identification
- NCT ID
- NCT02018562
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 50 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2015
- Primary completion
- Feb 20, 2017
- Completion
- May 20, 2017
- Last update posted
- Sep 18, 2024
2015 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02018562, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02018562 live on ClinicalTrials.gov.