Evaluation of a Tracheostomy Tube That Enables Communication

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Evaluation of a Tracheostomy Tube That Enables Communication in Ventilator Dependent Patients - A Pilot Study

Conditions
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Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life

Intervention / Treatment
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* Device: Portex Blueline Ultra Suctionaid Tracheostomy Tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The talking tracheostomy trial involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use. We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube. i. SLP will also assess the duration of successful speech during each session ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility. iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session. | Device: Portex Blueline Ultra Suctionaid Tracheostomy Tube<br> <br> |
| No Intervention: Control<br>This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Quality of Life in Mechanically Ventilated Patients Questionnaire (QOL-MV) was used to measure quality of life. It is a 12-item scale with each items 0 - 10 and total score ranges from 0 - 120. Lower scores refers to lower quality of life and Higher scores refer to higher level quality of life. To be assessed at baseline and 2 weeks post Portex Blueline Ultra Suctionaid (BLUSA). | Baseline; 2 weeks post BLUSA | 
| Change in Quality of Life | Voice-Related Quality of Life (V-RQOL). It is a 10-item scale with each items 2 - 10 and total score ranges from 20 - 100. Lower scores refers to higher quality of life and Higher scores refer to lower level quality of life. | Baseline; 2 weeks post BLUSA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Intelligibility | The Speech Intelligibility Test has 11 randomly computer generated sentences that patients are asked to read aloud. They are recorded and judged by an unfamiliar listener at a later time. Scores range from 0 - 100 with higher scores indicating greater level of speech intelligibility. | 2 weeks | 
| Level of Independence With Talking Tracheostomy Tube | Participants were asked how independently they thought they could use the tracheostomy tube. Will report the number of participants who indicated some level of independence. | 2 weeks | 
| Patient Satisfaction With a Talking Tracheostomy Tube | Participants were asked how satisfied they were with the tracheostomy tube. Will report the number of participants who indicated some level of satisfaction. | 2 weeks | 
| Overall Hospital Length of Stay | Measured in days | Time of discharge from the hospital (Approximately 6-8 months) | 
| Intensive Care Unit (ICU) Length of Stay | Measured in days | Time of discharge from the ICU (Approximately 6-8 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Talking Tracheostomy Tube, Speech, Mechanically ventilated patients