Evaluation of a Tracheostomy Tube That Enables Communication

Not Applicable

Completed

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

Interventions: Device: Portex Blueline Ultra Suctionaid Tracheostomy Tube

Registration Number: NCT02018562

Lead Sponsor: Johns Hopkins University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Portex Blueline Ultra Suctionaid Tracheostomy Tube	1. 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. 2. 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.

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life	Baseline; 2 weeks post BLUSA	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction With a Talking Tracheostomy Tube	2 weeks	Participants were asked how satisfied they were with the tracheostomy tube. Will report the number of participants who indicated some level of satisfaction.
Level of Independence With Talking Tracheostomy Tube	2 weeks	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.
Overall Hospital Length of Stay	Time of discharge from the hospital (Approximately 6-8 months)	Measured in days
Intensive Care Unit (ICU) Length of Stay	Time of discharge from the ICU (Approximately 6-8 months)	Measured in days
Speech Intelligibility	2 weeks	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.