Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tracheostomy Complication
- Sponsor
- Rush University Medical Center
- Locations
- 1
- Primary Endpoint
- Tidal volume from upper airway
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jie Li
Associate professor
Rush University Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Tidal volume from upper airway
Time Frame: within 1 minute of measuring patient's tidal volume
Tidal volume from upper airway during one-way speaking valve trial
Tran-tracheal pressure (TTP)
Time Frame: within 15 seconds of measuring TTP
Tran-tracheal pressure (TTP) during one-way speaking valve trial
leak volume [for mechanically ventilated patients only]
Time Frame: within 1 minute of measuring patient's leak volume
volume leaked from upper airway during invasive ventilation
Ultrasound results for upper-airway
Time Frame: 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
Time Frame: within 1 minute of measuring patient's inspiratory flow
Inspiratory flow from upper airway during one-way speaking valve trial
Secondary Outcomes
- Heart rate during one-way speaking valve trial(within 15 minutes of placing one-way speaking valve)
- SpO2 during one-way speaking valve trial(within 15 minutes of placing one-way speaking valve)
- Blood pressure during one-way speaking valve trial(within 15 minutes of placing one-way speaking valve)
- Respiratory rate during one-way speaking valve trial(within 15 minutes of placing one-way speaking valve)