N/A
N=50
Evaluation of a Tracheostomy Tube That Enables Communication
Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT02018562 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change in Quality of Life — 44.65; 42.78; 50.24; 49.41 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Portex Blueline Ultra Suctionaid Tracheostomy Tube (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life |
26.59; 26.67; 42.50; 32.26 | — |
| PRIMARY Change in Quality of Life |
26.59; 26.67; 42.50; 32.26 | — |
| SECONDARY Speech Intelligibility |
53.1 | — |
| SECONDARY Level of Independence With Talking Tracheostomy Tube |
16 | — |
| SECONDARY Patient Satisfaction With a Talking Tracheostomy Tube |
9 | — |
| SECONDARY Overall Hospital Length of Stay |
72.68; 48.84 | — |
| SECONDARY Intensive Care Unit (ICU) Length of Stay |
58.12; 39.04 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Mechanically ventilated via tracheostomy
- Awake, alert, and attempting to communicate
- Able to understand English
Exclusion Criteria
- Delirium
- Fresh tracheostomy within 48 hours
- Laryngectomy
Data sourced from ClinicalTrials.gov (NCT02018562). 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.