TracheostomyNCT07317791
Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients
A study testing standardized tracheostomy decannulation protocol in people with Tracheostomy, run by Hongying Jiang, MD at 5 sites in China.
Trial summary
Background: International studies have proposed a cough peak flow (CPF) of ≥160 L/min as a reference threshold for safe decannulation. However, this measurement requires prior removal of the tracheostomy tube, which is often difficult for Chinese patients and their families to accept due to cultural and safety… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tracheostomy
- What is being tested?
- standardized tracheostomy decannulation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Tracheostomy tube in place for ≥14 days
- Weaned from ventilator for more than 48 hours, or in a state of spontaneous breathing
- Patient and family members have provided informed consent
Who cannot join
- Severe craniofacial deformity preventing CFsv measurement
- Known obstructive upper airway pathology precluding tracheostomy tube removal
- Laryngopharyngeal trauma
- Inability to tolerate cuff deflation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043
Hongying Jiang, +861056981067, 6jhy@163.com
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Jiangbin, 530012
Li Zheng, 17776263283, 819237886@qq.com
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Henan, Zhengzhou, 450007
Yajing Wang, 86-15515645380, wangya568@163.com
Hunan Rehabilitation Hospital
Hunan, Hunan, 410000
Pan Li, 18674765825, 584703769@qq.com
YanBian University Hospital
Jilin City, Yanbian, 133000
Shenglan Jin, 04332660078, Shenglan91@163.com
About this study
Official title: Multicenter Prospective Validation of Cough Flow With Tracheostomy Tube and Speaking Valve (CFsv) >100 L/Min as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients
Background: International studies have proposed a cough peak flow (CPF) of ≥160 L/min as a reference threshold for safe decannulation. However, this measurement requires prior removal of the tracheostomy tube, which is often difficult for Chinese patients and their families to accept due to cultural and safety concerns. Additionally, there is a lack of rapid, user-friendly, and widely applicable quantitative tools in clinical practice within ICUs or rehabilitation specialties in China. Moreover, the heterogeneity among domestic patient populations with different underlying conditions (such as neuromuscular diseases, spinal cord injuries, stroke, and respiratory failure) makes it challenging to apply a single foreign-derived indicator. In our center's prospective study from 2019 to 2022(Respiratory Research 2024;25:128), the investigators proposed and preliminarily validated that a cough flow measured with tracheostomy tube and speaking valve (CFSV) >100 L/min could serve as a threshold for safe decannulation. Among 193 patients with long-term tracheostomy tubes, 105 were decannulated based on this threshold, with a success rate of 98.1%. Only two cases required reintubation within 48 hours (1.9%), and the six-month reintubation rate was 2.9%, which is significantly better than previously reported domestic and international data (reintubation rates of 5-15%). For patients with insufficient CFSV, after an average of 26 days of individualized cough enhancement rehabilitation, 91% achieved the threshold and ultimately succeeded in decannulation. This suggests that 100 L/min may be a more physiologically appropriate threshold for Chinese (and even East Asian) populations with indwelling tracheostomy tubes, and that CFSV combined with systematic rehabilitation interventions can significantly improve decannulation rates. However, these conclusions are derived from single-center data with a limited sample size, and the diversity of diseases and regional variations in medical standards may affect generalizability. Therefore, there is an urgent need for multicenter, large-sample prospective studies to validate the effectiveness, accuracy, and feasibility of CFSV >100 L/min as a quantitative standard for safe decannulation.
- Conditions
- Tracheostomy
- Being tested
- standardized tracheostomy decannulation protocol
- Keywords
- Decannulation, Cough peak flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized tracheostomy decannulation protocolOther
Step 1: Confirm that the patient is clinically stable. Step 2: Speaking valve (SV) with transtracheal end-expiratory pressure (TTPEE) measurement.
Step 3: Measure the CFsv. Step 4: Continue wearing the SV for 4 hours. During this period, suctioning is not performed via the tracheostomy tube.
Step 5: Assess readiness for decannulation. The CFsv is measured again prior to decannulation. If the value exceeds 100 L/min, decannulation is performed.
| Study group | Role | What they receive |
|---|---|---|
| Decannulation Protocol Group | Experimental | all patients included in the study will undergo standardized decannulation assessment. Receives: Other: standardized tracheostomy decannulation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decannulation Success
No requirement for tracheostomy tube reinsertion within 48 hours after decannulation
Measured: 48 hours post-decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongying Jiang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongying Jiang, MD, Capital Medical University
- Investigators
- Hongying Jiang, MD, Study chair, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317791
- Sponsor's protocol ID
- 2025-hxkfzx-dzx-002
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Validation of Cough Flow With Tracheostomy Tube and Speaking Valve (CFsv) >100 L/Min as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients
- ClinicalTrials.gov ID
- NCT07317791
- Acronym / sponsor ID
- 2025-hxkfzx-dzx-002
- Conditions
- Tracheostomy
- Keywords
- Decannulation, Cough peak flow
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hongying Jiang, MDUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Jan 2026 (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.
Background: International studies have proposed a cough peak flow (CPF) of ≥160 L/min as a reference threshold for safe decannulation. However, this measurement requires prior removal of the tracheostomy tube, which is often difficult for Chinese patients and their families to accept due to cultural and safety concerns. Additionally, there is a lack of rapid, user-friendly, and widely applicable quantitative tools in clinical practice within ICUs or rehabilitation specialties in China. Moreover, the heterogeneity among domestic patient populations with different underlying conditions (such as neuromuscular diseases, spinal cord injuries, stroke, and respiratory failure) makes it challenging to apply a single foreign-derived indicator. In our center's prospective study from 2019 to 2022(Respiratory Research 2024;25:128), the investigators proposed and preliminarily validated that a cough flow measured with tracheostomy tube and speaking valve (CFSV) >100 L/min could serve as a threshold for safe decannulation. Among 193 patients with long-term tracheostomy tubes, 105 were decannulated based on this threshold, with a success rate of 98.1%. Only two cases required reintubation within 48 hours (1.9%), and the six-month reintubation rate was 2.9%, which is significantly better than previously reported domestic and international data (reintubation rates of 5-15%). For patients with insufficient CFSV, after an average of 26 days of individualized cough enhancement rehabilitation, 91% achieved the threshold and ultimately succeeded in decannulation. This suggests that 100 L/min may be a more physiologically appropriate threshold for Chinese (and even East Asian) populations with indwelling tracheostomy tubes, and that CFSV combined with systematic rehabilitation interventions can significantly improve decannulation rates. However, these conclusions are derived from single-center data with a limited sample size, and the diversity of diseases and regional variations in medical standards may affect generalizability. Therefore, there is an urgent need for multicenter, large-sample prospective studies to validate the effectiveness, accuracy, and feasibility of CFSV >100 L/min as a quantitative standard for safe decannulation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decannulation Protocol Group | Experimental | Other: standardized tracheostomy decannulation protocolall patients included in the study will undergo standardized decannulation assessment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Tracheostomy tube in place for ≥14 days
- Weaned from ventilator for more than 48 hours, or in a state of spontaneous breathing
- Patient and family members have provided informed consent
Key exclusion criteria (4 listed)
- Severe craniofacial deformity preventing CFsv measurement
- Known obstructive upper airway pathology precluding tracheostomy tube removal
- Laryngopharyngeal trauma
- Inability to tolerate cuff deflation
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 |
|---|---|---|
| standardized tracheostomy decannulation protocolStep 1: Confirm that the patient is clinically stable. Step 2: Speaking valve (SV) with transtracheal end-expiratory pressure (TTPEE) measurement. Step 3: Measure the CFsv. Step 4: Continue wearing the SV for 4 hours. During this period, suctioning is not performed via the tracheostomy tube. Step 5: Assess readiness for decannulation. The CFsv is measured again prior to decannulation. If the value exceeds 100 L/min, decannulation is performed. | Other | Decannulation Protocol Group |
Primary outcome
Decannulation Success
Time frame: 48 hours post-decannulation
No requirement for tracheostomy tube reinsertion within 48 hours after decannulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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.
Hongying Jiang, MD study chair
Beijing Rehabilitation Hospital of Capital Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized tracheostomy decannulation protocol in people with Tracheostomy, run by Hongying Jiang, MD at 5 sites 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyi Ge (+861056981098, ge_jingyi2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decannulation Success (time frame: 48 hours post-decannulation). 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 21 Jan 2026.