Clinical trial NCT02018562: Evaluation of a Tracheostomy Tube That Enables Communication
Official title: Prospective Evaluation of a Tracheostomy Tube That Enables Communication in Ventilator Dependent Patients - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life
Keywords: Quality of Life
Talking Tracheostomy Tube
Speech
Mechanically ventilated patients
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline; 2 weeks post BLUSA
measure: Change in Quality of Life
timeFrame: Baseline; 2 weeks post BLUSA
Secondary outcomes:
measure: Speech Intelligibility
timeFrame: 2 weeks
measure: Level of Independence With Talking Tracheostomy Tube
timeFrame: 2 weeks
measure: Patient Satisfaction With a Talking Tracheostomy Tube
timeFrame: 2 weeks
measure: Overall Hospital Length of Stay
timeFrame: Time of discharge from the hospital (Approximately 6-8 months)
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: Time of discharge from the ICU (Approximately 6-8 months)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
References:
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citation: Pandian V, Cole T, Kilonsky D, Holden K, Feller-Kopman DJ, Brower R, Mirski M. Voice-Related Quality of Life Increases With a Talking Tracheostomy Tube: A Randomized Controlled Trial. Laryngoscope. 2020 May;130(5):1249-1255. doi: 10.1002/lary.28211. Epub 2019 Aug 6.