Evaluation of a Tracheostomy Tube That Enables Communication (BLUSA)

Johns Hopkins University

Status: Completed

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

Treatments: Device: Portex Blueline Ultra Suctionaid Tracheostomy Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02018562

NA_00086689

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Device: Portex Blueline Ultra Suctionaid Tracheostomy Tube

Control

No Intervention group

Description:

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