Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients

Capital Medical University

Status: Completed

Conditions: Tracheotomy

Treatments: Diagnostic Test: speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06521320

2021Z-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

248 participants in 2 patient groups

Upper airway patency

Experimental group

Description:

Upper airway patency confirmed by speaking valve combined with airway pressure measurement or bronchoscopy

Treatment:

Diagnostic Test: Bronchoscopy

Diagnostic Test: speaking valve combined with airway pressure

Upper airway obstruction

Experimental group

Description:

Upper airway obstruction confirmed by speaking valve combined with airway pressure measurement or bronchoscopy

Treatment:

Diagnostic Test: Bronchoscopy

Diagnostic Test: speaking valve combined with airway pressure