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

NCT06521320 | Completed DMC

• 1 other identifier: 2021Z-001
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheotomy

Keywords

upper airway patency; speaking valve; upper airway; prolonged tracheostomized patients; transtracheal end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

• Upper airway patency

  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.

  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.

Study Arms (2)

Upper airway patency

EXPERIMENTAL

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

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

Upper airway obstruction

EXPERIMENTAL

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

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

Interventions

speaking valve combined with airway pressure DIAGNOSTIC_TEST

All patients were given speaking valves and airway pressure was measured to assess upper airway patency.

Upper airway obstruction; Upper airway patency

Bronchoscopy DIAGNOSTIC_TEST

The same examiner performed bronchoscopy on all patients to assess upper airway patency.

Upper airway obstruction; Upper airway patency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Rehabilitation Hospital of Capital Medical University

Beijing, China

Location

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Jingyi Ge

  specify unaffiliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients were given a speaking valve combined with airway pressure measurement and bronchoscopy.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 25, 2024
• Study Start: October 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)