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临床试验/NCT06521320
NCT06521320已完成不适用

Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients: a Prospective Cohort Study

Capital Medical University1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
248
试验地点
1
主要终点
Upper airway patency

研究概览

简要总结

This study was aimed to evaluate whether speaking valve combined with airway pressure could predict upper airway patency non-invasively in prolonged tracheostomized patients, identify candidates who need following endoscopy examination.

详细描述

Tracheotomy is an effective means of treating critically ill patients, but its postoperative management faces many challenges, especially in the assessment and monitoring of upper airway patency. Although the indwelling tracheostomy tube plays an important role in maintaining airway patency and assisting breathing, it may also cause a series of complications, including airway stenosis, granulation tissue hyperplasia, airway collapse, and laryngeal dysfunction. The patency of the upper airway after tracheotomy is directly related to the patient's spontaneous breathing ability and quality of life. Although the existing bronchoscopy provides accurate diagnostic information, its invasiveness and high cost limit its application in extensive and high-frequency monitoring. Finding a non-invasive, easy-to-operate and accurate alternative method is of great clinical significance.The speaking valve is a one-way valve placed at the end of the tracheostomy tube that directs airflow to the upper airway when the cuff is deflated. Airway pressure measurement is a simple, non-invasive method that measures the pressure inside the tracheostomy tube to infer airway patency and resistance levels. Combining the two for a systematic assessment of upper airway patency in tracheostomy patients may provide a new, efficient, non-invasive monitoring tool for the clinic. By comparing the results of speaking valve combined with airway pressure measurement with the "gold standard" bronchoscopy results, its sensitivity and accuracy in assessing upper airway patency are verified, which is expected to not only provide a non-invasive, easier-to-use bedside assessment tool, but also improve the quality of patient care and their quality of life. Our hospital's respiratory rehabilitation center has the appropriate infrastructure and professional staffing to conduct research safely and in a standardized manner.

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

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
  • Unable tolerance of cuff deflated
  • 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

结局指标

主要结局

Upper airway patency

时间窗: The patients started using the speaking valve combined with airway pressure measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.

Speaking valve combined with airway pressure protocol: After suction of oral and nasal secretion, the cuff was deflated. Then the speaking valve was placed. Supplement oxygen could be provided from nose. Connect a pressure measuring device for airway pressure. Then the tracheostomy tube was downsized according to patient's status (This decision was decided by a multidisciplinary team through consultation). Patients who could tolerate speaking valve and airway pressure\<10cmH2O were assumed Upper airway patency group. Patients who cannot tolerate the speaking valve or whose airway pressure is ≥10cmH2O even after downsizing the tracheostomy are in the Upper airway obstruction group. Bronchoscopy protocol: Use bronchoscopy through nose to observe the upper airway through the glottis and around the cuff. Patients with bilateral vocal cord distance \<3 mm or Cotton grade II or above were considered to have upper airway obstruction during bronchoscopy evaluation.

次要结局

未报告次要终点

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingyi Ge

Principal Investigator

Capital Medical University

研究点 (1)

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