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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Tracheostomy Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with tracheostomy

Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial

One-way speaking valve

Intervention Type DEVICE

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.

Interventions

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One-way speaking valve

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.

Intervention Type DEVICE

Other Intervention Names

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Passy muir valve

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