Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial
- Conditions
- Tracheostomy Complication
- Interventions
- Device: One-way speaking valve
- Registration Number
- NCT04685902
- Lead Sponsor
- Rush University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Laryngectomy
- Uncorrected anatomical anomalies
- Unable to communicate
- Hemodynamically unstable
- Refuse to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult patients with tracheostomy One-way speaking valve Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial
- Primary Outcome Measures
Name Time Method 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
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)
- Secondary Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States