TracheotomyNCT06521320
Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients
A study testing speaking valve combined with airway pressure and Bronchoscopy in people with Tracheotomy, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheotomy
- What is being tested?
- speaking valve combined with airway pressure and Bronchoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Beijing Rehabilitation Hospital of Capital Medical University
Beijing
About this study
Official title: Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients: a Prospective Cohort Study
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.
Read the 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.
- Conditions
- Tracheotomy
- Being tested
- speaking valve combined with airway pressure, Bronchoscopy
- Keywords
- upper airway patency, speaking valve, upper airway, prolonged tracheostomized patients, transtracheal end-expiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speaking valve combined with airway pressureDiagnostic test
All patients were given speaking valves and airway pressure was measured to assess upper airway patency.
BronchoscopyDiagnostic test
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
| Study group | Role | What they receive |
|---|---|---|
| Upper airway patency | Experimental | Upper airway patency confirmed by speaking valve combined with airway pressure measurement or bronchoscopy Receives: 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 Receives: Diagnostic Test: speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Oct 2021
- Primary completion30 Apr 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheotomyStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All patients were given a speaking valve combined with airway pressure measurement and bronchoscopy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ge, Capital Medical University
- Investigators
- Jingyi Ge, Principal investigator, specify unaffiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521320
- Sponsor's protocol ID
- 2021Z-001
- Status last verified
- Sep 2024
- First submitted
- 12 Jul 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06521320
- Acronym / sponsor ID
- 2021Z-001
- Conditions
- Tracheotomy
- Keywords
- upper airway patency, speaking valve, upper airway, prolonged tracheostomized patients, transtracheal end-expiratory pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All patients were given a speaking valve combined with airway pressure measurement and bronchoscopy.
| Arm | Type | Receives |
|---|---|---|
| Upper airway patency | Experimental | Diagnostic Test: speaking valve combined with airway pressure, Diagnostic Test: BronchoscopyUpper airway patency confirmed by speaking valve combined with airway pressure measurement or bronchoscopy |
| Upper airway obstruction | Experimental | Diagnostic Test: speaking valve combined with airway pressure, Diagnostic Test: BronchoscopyUpper airway obstruction confirmed by speaking valve combined with airway pressure measurement or bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Weaned from ventilator more than 48 hours
- No any organ failure
- No sepsis
- Stable heart rate and blood pressure
- Lung infection under control
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speaking valve combined with airway pressureAll patients were given speaking valves and airway pressure was measured to assess upper airway patency. | Diagnostic test | Upper airway obstruction, Upper airway patency |
| BronchoscopyThe same examiner performed bronchoscopy on all patients to assess upper airway patency. | Diagnostic test | Upper airway obstruction, Upper airway patency |
Primary outcome
Upper airway patency
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyi Ge principal investigator
specify unaffiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speaking valve combined with airway pressure and Bronchoscopy in people with Tracheotomy, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper airway patency (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.