Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial

Study Overview
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Brief Summary
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Approximately 24% of ICU patients require the use of a tracheostomy, which impacts vocalization. A one-way speaking valve (SV) can be used to restore vocalization for this patient population. However, if a patient has an obstructed upper airway, SV placement has potential to pose a risk as it might cause asphyxia or even cardiac arrest within minutes, due to the sudden increased intra-thoracic pressure and decreased venous return. Therefore, upper airway patency is crucial in the patient's tolerability and safety to use SV. However, little is available to assess patient's upper airway patency before SV placement. Currently, the predominate way to evaluate readiness is the clinician's subjective assessment based on the quality of vocalization, perceived comfort, and tolerance following SV placement. In the previous in vitro study, the upper airway patency was strongly correlated with the trans-tracheal pressure and the inspiratory flow from upper airway during SV trial. Thus this clinical prospective observational study is aimed to validate the two methods with upper airway patency, which will be validated by bedside ultrasound examination as well.

Official Title
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Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial

Conditions
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Tracheostomy Complication

Intervention / Treatment
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* Device: One-way speaking valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Current RUMC patient An order for a one-way speaking valve trial Tracheostomy PEEP ≤ 10 cm H2O and FIO2 ≤ 50% English speaking Exclusion Criteria: Laryngectomy Uncorrected anatomical anomalies Unable to communicate Hemodynamically unstable Refuse to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patients with tracheostomy<br>Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial | Device: One-way speaking valve<br>* One-way speaking valve is a small device that attaches to the tracheostomy tube, to allows tracheostomy patient to breathe in through his or her trach tube. After the inhalation, the speaking valve closes. Air is breathed out (exhaled) up through the vocal cords, then through the mouth and nose.<br>* Other names: Passy muir valve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory flow from upper airway | Inspiratory flow from upper airway during one-way speaking valve trial | within 1 minute of measuring patient's inspiratory flow | 
| Tidal volume from upper airway | Tidal volume from upper airway during one-way speaking valve trial | within 1 minute of measuring patient's tidal volume | 
| Tran-tracheal pressure (TTP) | Tran-tracheal pressure (TTP) during one-way speaking valve trial | within 15 seconds of measuring TTP | 
| leak volume [for mechanically ventilated patients only] | volume leaked from upper airway during invasive ventilation | within 1 minute of measuring patient's leak volume | 
| Ultrasound results for upper-airway | Ultrasound results include pre-epiglottic space distance/epiglottitis to middle distance of vocal cords (Pre-E/E-VC), thyrohyoid membrane (DSEM), and hyomental distance ratio (HMDR) | within 10 minutes of the ultrasound examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate during one-way speaking valve trial | Heart rate during one-way speaking valve trial | within 15 minutes of placing one-way speaking valve | 
| Respiratory rate during one-way speaking valve trial | Respiratory rate during one-way speaking valve trial | within 15 minutes of placing one-way speaking valve | 
| SpO2 during one-way speaking valve trial | SpO2 during one-way speaking valve trial | within 15 minutes of placing one-way speaking valve | 
| Blood pressure during one-way speaking valve trial | Blood pressure during one-way speaking valve trial | within 15 minutes of placing one-way speaking valve | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, Upper airway patency, speaking valve, Ultrasound