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

Not Applicable

Completed

• Conditions: Tracheotomy
• Interventions: Diagnostic Test: speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy

• Registration Number: NCT06521320
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2024-04-30
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-25
• Status Verified: 2024-09
• Study Completion: 2024-09-30
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Upper airway patency	speaking valve combined with airway pressure	Upper airway patency confirmed by speaking valve combined with airway pressure measurement or bronchoscopy
Upper airway obstruction	speaking valve combined with airway pressure	Upper airway obstruction confirmed by speaking valve combined with airway pressure measurement or bronchoscopy
Upper airway patency	Bronchoscopy	Upper airway patency confirmed by speaking valve combined with airway pressure measurement or bronchoscopy
Upper airway obstruction	Bronchoscopy	Upper airway obstruction confirmed by speaking valve combined with airway pressure measurement or bronchoscopy

Primary Outcome Measures

Name	Time	Method
Upper airway patency	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.

Trial Locations

Locations (1)

Beijing Rehabilitation Hospital of Capital Medical University; 🇨🇳 Beijing, China