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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

Other trials in China

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 groups in NCT07317791
Study groupRoleWhat they receive
Decannulation Protocol GroupExperimentalall 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.

  1. 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.

  1. First posted5 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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)
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

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.

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