Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial
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
- 否
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
Jie Li
Associate professor
Rush University Medical Center
