Speaking Valves With Transtracheal End-expiratory Pressure Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients: A Multicenter, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency
研究概览
简要总结
The aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Weaned from ventilator more than 48 hours
- •No any organ failure
- •No sepsis
- •Stable heart rate and blood pressure
- •Lung infection under control
- •PCO2<60mmHg
- •Patient and family sign informed consent form
排除标准
- •Serious dysfunction of vital organs
- •Inability to tolerate cuff deflation
- •Laryngopharyngeal trauma
- •Known severe upper airway obstruction before referrer to our department
- •Endoscopy(bronchoscopy or laryngoscopy) has been performed and the condition of the upper airway has known
研究组 & 干预措施
True positive group
Upper airway non-patency is defined as positive; otherwise, it is negative. The true positive group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are positive.
干预措施: Speaking valve combined with airway pressure (Diagnostic Test)
True positive group
Upper airway non-patency is defined as positive; otherwise, it is negative. The true positive group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are positive.
干预措施: Bronchoscopy (Diagnostic Test)
False positive group
Upper airway non-patency is defined as positive; otherwise, it is negative. The false positive group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is positive, and the result of the bronchoscopy is negative.
干预措施: Speaking valve combined with airway pressure (Diagnostic Test)
False positive group
Upper airway non-patency is defined as positive; otherwise, it is negative. The false positive group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is positive, and the result of the bronchoscopy is negative.
干预措施: Bronchoscopy (Diagnostic Test)
True negative group
Upper airway non-patency is defined as positive; otherwise, it is negative. The true negative group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are negative.
干预措施: Speaking valve combined with airway pressure (Diagnostic Test)
True negative group
Upper airway non-patency is defined as positive; otherwise, it is negative. The true negative group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are negative.
干预措施: Bronchoscopy (Diagnostic Test)
False negative group
Upper airway non-patency is defined as positive; otherwise, it is negative. The false negative group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is negative, and the result of the bronchoscopy is positive.
干预措施: Speaking valve combined with airway pressure (Diagnostic Test)
False negative group
Upper airway non-patency is defined as positive; otherwise, it is negative. The false negative group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is negative, and the result of the bronchoscopy is positive.
干预措施: Bronchoscopy (Diagnostic Test)
结局指标
主要结局
The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency
时间窗: The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.
Patients enrolled in the study will undergo both SV with transtracheal end-expiratory pressure measurement and bronchoscopy. Upper airway non-patency will be defined as positive. Using the results of bronchoscopy as the gold standard, the sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement will be evaluated.
次要结局
未报告次要终点
研究者
Hongying Jiang
Sponsor-Investigator
Capital Medical University