Evaluation of a Tracheostomy Tube That Enables Communication (BLUSA)

March 27, 2018 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
  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.
Device: Portex Blueline Ultra Suctionaid Tracheostomy Tube
NO_INTERVENTION: Control
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: Baseline; 2 weeks post BLUSA
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
Time Frame: 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.
Baseline; 2 weeks post BLUSA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Intelligibility
Time Frame: 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.
2 weeks
Level of Independence With Talking Tracheostomy Tube
Time Frame: 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.
2 weeks
Patient Satisfaction With a Talking Tracheostomy Tube
Time Frame: 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.
2 weeks
Overall Hospital Length of Stay
Time Frame: Time of discharge from the hospital (Approximately 6-8 months)
Measured in days
Time of discharge from the hospital (Approximately 6-8 months)
Intensive Care Unit (ICU) Length of Stay
Time Frame: Time of discharge from the ICU (Approximately 6-8 months)
Measured in days
Time of discharge from the ICU (Approximately 6-8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

February 21, 2017

Study Completion (ACTUAL)

May 21, 2017

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (ESTIMATE)

December 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NA_00086689

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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