Clinical trial NCT06521320: Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients
Official title: Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheotomy
Keywords: upper airway patency
speaking valve
upper airway
prolonged tracheostomized patients
transtracheal end-expiratory pressure
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All patients were given a speaking valve combined with airway pressure measurement and bronchoscopy.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Upper airway patency
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Rehabilitation Hospital of Capital Medical University
Study officials:
affiliation: specify unaffiliated
name: Jingyi Ge
role: PRINCIPAL_INVESTIGATOR
References: