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临床试验/NCT04685902
NCT04685902撤回不适用

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

Rush University Medical Center1 个研究点 分布在 1 个国家开始时间: 2022年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Tidal volume from upper airway

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Laryngectomy
  • Uncorrected anatomical anomalies
  • Unable to communicate
  • Hemodynamically unstable
  • Refuse to participate in the study

结局指标

主要结局

Tidal volume from upper airway

时间窗: within 1 minute of measuring patient's tidal volume

Tidal volume from upper airway during one-way speaking valve trial

Tran-tracheal pressure (TTP)

时间窗: within 15 seconds of measuring TTP

Tran-tracheal pressure (TTP) during one-way speaking valve trial

leak volume [for mechanically ventilated patients only]

时间窗: within 1 minute of measuring patient's leak volume

volume leaked from upper airway during invasive ventilation

Ultrasound results for upper-airway

时间窗: 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

时间窗: within 1 minute of measuring patient's inspiratory flow

Inspiratory flow from upper airway during one-way speaking valve trial

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jie Li

Associate professor

Rush University Medical Center

研究点 (1)

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