Skip to main content
Clinical Trials/NCT04685902
NCT04685902
Withdrawn
Not Applicable

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

Rush University Medical Center1 site in 1 countryJune 2022

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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
June 2022
End Date
December 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

Loading locations...

Similar Trials