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Completed

NCT Number: NCT02018562

Evaluation of a Tracheostomy Tube That Enables Communication

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Portex Blueline Ultra Suctionaid Tracheostomy Tube

Device

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. Overall Hospital Length of Stay

    Time frame: Time of discharge from the hospital (Approximately 6-8 months)

    Measured in days

  5. Intensive Care Unit (ICU) Length of Stay

    Time frame: Time of discharge from the ICU (Approximately 6-8 months)

    Measured in days

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: BLUSA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2013
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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