An observational study in Tracheostomy Complication, sponsored by Rush University Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-07.
Sponsored by Rush University Medical Center · Observational
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.
Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial will be recruited from Rush University Medical Center, Chicago, IL.
Exclusion Criteria:
Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial
Device: 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.
Also known as: Passy muir valve
Inspiratory flow from upper airway
Inspiratory flow from upper airway during one-way speaking valve trial
Time frame: 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
Time frame: within 1 minute of measuring patient's tidal volume
Tran-tracheal pressure (TTP)
Tran-tracheal pressure (TTP) during one-way speaking valve trial
Time frame: within 15 seconds of measuring TTP
leak volume [for mechanically ventilated patients only]
volume leaked from upper airway during invasive ventilation
Time frame: 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)
Time frame: within 10 minutes of the ultrasound examination
Heart rate during one-way speaking valve trial
Heart rate during one-way speaking valve trial
Time frame: 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
Time frame: within 15 minutes of placing one-way speaking valve
SpO2 during one-way speaking valve trial
SpO2 during one-way speaking valve trial
Time frame: 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
Time frame: within 15 minutes of placing one-way speaking valve
Plan to share: No — Due to HIPAA, we would not share the individual participant data
This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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