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

NCT04685902 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-03-07

No results posted yet for this study

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.

Conditions

  • Tracheostomy Complication

Interventions

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.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Jie Li, PhD · Rush University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685902 on ClinicalTrials.gov