Tracheostomy Complication
Conditions
Keywords
Tracheostomy, Upper airway patency, speaking valve, Ultrasound
Brief summary
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.
Interventions
DEVICEOne-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.
Sponsors
Rush University Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound results for upper-airway | within 10 minutes of the ultrasound examination | 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) |
| Inspiratory flow from upper airway | within 1 minute of measuring patient's inspiratory flow | Inspiratory flow from upper airway during one-way speaking valve trial |
| Tidal volume from upper airway | within 1 minute of measuring patient's tidal volume | Tidal volume from upper airway during one-way speaking valve trial |
| Tran-tracheal pressure (TTP) | within 15 seconds of measuring TTP | Tran-tracheal pressure (TTP) during one-way speaking valve trial |
| leak volume [for mechanically ventilated patients only] | within 1 minute of measuring patient's leak volume | volume leaked from upper airway during invasive ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate during one-way speaking valve trial | within 15 minutes of placing one-way speaking valve | Respiratory rate during one-way speaking valve trial |
| SpO2 during one-way speaking valve trial | within 15 minutes of placing one-way speaking valve | SpO2 during one-way speaking valve trial |
| Blood pressure during one-way speaking valve trial | within 15 minutes of placing one-way speaking valve | Blood pressure during one-way speaking valve trial |
| Heart rate during one-way speaking valve trial | within 15 minutes of placing one-way speaking valve | Heart rate during one-way speaking valve trial |
Countries
United States
Outcome results
None listed