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Completed

NCT Number: NCT01784224

A Comparison of the Blom Low Profile Voice Inner Cannula and the Passy-Muir One-Way Tracheotomy Tube Speaking Valve on Voice Production, Speech Intelligibility, and Biomechanical Swallowing Behavior

The main purpose of this study is to investigate voice production, speech intelligibility and routine physiologic parameters associated with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves.

Additionally, the purpose of this study is to investigate the effects (if any) associated with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves on swallowing behavior and biomechanical movement of the hyolaryngeal complex during routine diagnostic modified barium swallowing evaluations.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, United States

About this study

The goal of a one-way tracheotomy tube speaking valve is to allow cognitively intact individuals who require a tracheotomy tube communicate with their own voice. All non-verbal communication strategies have shortcomings. Lip reading is unreliable, communication boards are simplistic, writing very laborious, and computerized augmentative communication systems too costly. This inability to communicate effectively prevents optimal patient participation in their plan-of-care. Verbal communication, therefore, plays an integral role in psychological functioning, social interactions, and overall medical care.

The primary criteria for determining success or failure of any one-way tracheotomy tube speaking valve is how well it allows for adequate voice intensity greater than ambient room noise to achieve both audible voice production and intelligible speech. The first purpose of this study is to investigate voice production and speech intelligibility abilities associated with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves. It is hypothesized that there will be no significant differences between the two speaking valves regarding physiologic parameters, voice production, or speech intelligibility capabilities.

There are conflicting reports in the literature regarding the relationship between a tracheotomy tube and swallowing success. Some authors report an improvement in swallowing success when the tracheotomy tube is occluded while others report no change in aspiration status based on occlusion status of the tracheotomy tube. Recently, it has been reported that there was no causal relationship between the tracheotomy tube and aspiration status. There is a paucity of research, to date, reporting on movement of the hyolaryngeal complex based upon occlusion status of a tracheotomy tube or presence of a tracheotomy tube. The second purpose of this study is to investigate how the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves impact on swallowing behavior and movement of the hyolaryngeal complex during routine diagnostic modified barium swallow evaluations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years of age, English speaking, and ability to tolerate a tracheotomy tube with a fully deflated tracheotomy tube cuff.

Exclusion criteria

  • Inability to tolerate full tracheotomy tube cuff deflation or copious secretions preventing placement of a one-way tracheotomy tube speaking valve.

Treatment and study plan

Blom Low Profile Voice Cannula/Passty-Muir Speaking Valves

Procedure

Primary outcomes

  1. Maximum Duration of Voicing (seconds)

    Time frame: 30 minutes

    Maximum duration of voicing (seconds) will be obtained, after instructing the patient to say the vowel /a/ as long as possible timed with a stopwatch.

  2. Maximum Voice Intensity (dBA scale)

    Time frame: 30 minutes

    Maximum voice intensity (on the dBA scale) will be obtained, after instructing the patient to say the vowel /a/ as loud as possible, using a digital sound level meter placed 15 cm from the patient's lips.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2013
Registry last updated
Jun 13, 2014

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.