Tracheostomy DecannulationNCT07191509
Effects of Tracheostomy Decannulation on Respiratory Function
An observational study of Tracheostomy Decannulation, run by Capital Medical University at 1 site in China.
Trial summary
This single-center prospective study enrolls adult patients with long-term tracheostomy who are ready for tube removal (decannulation). Twenty-four hours before decannulation, each participant will receive three physiologic tests-breathing through the tracheostomy tube, breathing with a one-way speaking valve, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Decannulation
- What is being tested?
- Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years) in-patients with a pre-existing tracheostomy who are receiving multidisciplinary rehabilitation care at the Respiratory Rehabilitation Center of Beijing Rehabilitation Hospital, Capital Medical University. All candidates have a stable primary illness, are clinically judged ready for elective decannulation, can tolerate a one-way speaking valve for at least 4 hours, and are able to cooperate with bedside spirometry tests. Both sexes and all underlying diagnoses that required tracheostomy (e.g., neurologic, traumatic, postsurgical or pulmonary conditions) are eligible provided they meet the inclusion/exclusion criteria.
Who may be able to join
- Age ≥ 18 years.
- Tracheostomised patient whose primary illness is stable and who is scheduled for elective decannulation in the rehabilitation unit.
- Able to tolerate a one-way speaking valve for ≥ 4 h on the day before planned decannulation.
- Capable of following instructions and completing bedside spirometry.
- Patient (or legally authorised representative) has provided written informed consent.
Who cannot join
- No tracheostomy in place or requirement for re-intubation/re-cannulation after planned decannulation.
- Inability to perform lung-function testing either via the tracheostomy tube or via the mouth/nose (e.g., severe upper-airway obstruction, facial deformity).
- Unstable cardiopulmonary or neurological status that makes spirometry unsafe (e.g., ongoing myocardial ischemia, uncontrolled arrhythmia, severe agitation).
- Any acute condition requiring isolation precautions that preclude study procedures.
- Refusal or inability to sign informed consent.
- Missing or incomplete key outcome data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Rehabilitation Hospital, Capital Medical University
Beijing
Hongying Jiang, +8656981555, 6jhy@163.com
About this study
Official title: Study on the Impact of Tracheostomy Decannulation on Pulmonary Function in Adult Patients
This single-center prospective study enrolls adult patients with long-term tracheostomy who are ready for tube removal (decannulation). Twenty-four hours before decannulation, each participant will receive three physiologic tests-breathing through the tracheostomy tube, breathing with a one-way speaking valve, and breathing with the tube capped. Standard pulmonary-function and arterial-blood-gas measurements will be taken during each test and again 5 days after the tube is removed. The study compares these methods to identify which pre-decannulation test best predicts safe, successful decannulation and to describe the overall impact of tube removal on respiratory function.
- Conditions
- Tracheostomy Decannulation
- Being tested
- Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation
- Keywords
- Speaking Valve, Pulmonary Function Test, Tracheostomy Tube Occlusion, Tracheostomy Decannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube VentilationDevice
Speaking Valve:
Participants are assessed while breathing through a one-way speaking valve attached to the tracheostomy tube. The valve directs exhaled air through the upper airway, restoring phonation and more closely simulating post-decannulation airflow. The assessment is performed for up to 4 hours to evaluate tolerance and respiratory function prior to tracheostomy tube removal.
Tracheostomy Tube Occlusion:
Participants undergo a capping trial, in which the tracheostomy tube is completely occluded. During this intervention, patients must breathe entirely through their natural upper airway, which increases airway resistance and tests their ability to tolerate decannulation. The capping trial is conducted for 24-48 hours, with monitoring for signs of intolerance.
Tracheostomy Tube Ventilation:
This intervention involves assessment of respiratory function while the participant breathes directly through the open tracheostomy tube, representing the baseline state prior to any decannu
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Vital Capacity (FVC) [L]
FVC is obtained with a calibrated portable spirometer. Three acceptable manoeuvres are performed and the highest value kept. Baseline is recorded on Day -1 while the tracheostomy tube is capped; the same test is repeated on Day +5 during oral breathing after successful decannulation. The endpoint is the mean change (Day +5 minus Day -1) in liters; higher values indicate better respiratory function.
Measured: Baseline (Day -1) and Day +5 after decannulation.
Secondary outcomes (10)
Change in Forced Expiratory Volume in 1 Second (FEV1) [L]
Same measurement procedure as for FVC; endpoint is mean change in liters from Day -1 (capped) to Day +5 (oral).
Measured: Baseline (Day -1) and Day +5 after decannulation.
Change in FEV1/FVC Ratio [%]
Calculated from simultaneously measured FEV1 and FVC (FEV1 ÷ FVC × 100). Endpoint is mean percent change between Day -1 and Day +5.
Measured: Baseline (Day -1) and Day +5 after decannulation.
Change in Tidal Volume (VT) [mL]
Average VT of three consecutive quiet breaths recorded by spirometer under the same two time points; higher values denote better function.
Measured: Baseline (Day -1) and Day +5 after decannulation.
Change in Minute Ventilation (VE) [L/min]
VE calculated automatically by the spirometer (VT × breathing frequency). Endpoint is mean change from Day -1 to Day +5.
Measured: Baseline (Day -1) and Day +5 after decannulation.
Change in Maximum Voluntary Ventilation (MVV) [L/min]
Twelve-second MVV manoeuvre converted to one-minute value; mean change between Day -1 and Day +5.
Measured: Baseline (Day -1) and Day +5 after decannulation.
Change in Breathing Frequency (BF) [breaths/min]
Breaths per minute recorded by spirometer during quiet breathing; mean change from baseline to Day +5 (lower values indicate improvement).
Measured: Baseline (Day -1) and Day +5 after decannulation.
Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂) [mm Hg]
Same blood-gas procedure; endpoint is mean change in PaCO₂.
Measured: Day -1 and Day +5.
Change in Arterial Oxygen Partial Pressure (PaO₂) [mm Hg]
Arterial blood gas sample taken immediately after pulmonary function test at each time point; endpoint is mean change in PaO₂ (mm Hg).
Measured: Day -1 and Day +5.
Change in Blood pH [unitless]
Arterial blood pH measured together with gases; endpoint is mean change (Day -1 to Day +5).
Measured: Day -1 and Day +5.
Change in Base Excess (BE) [mmol/L]
Base Excess from arterial blood gas analysis; endpoint is mean change between the two time points.
Measured: Day -1 and Day +5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy DecannulationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ge, Capital Medical University
- Investigators
- Hongying Jiang, Study chair, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191509
- Sponsor's protocol ID
- 2025-HXKFZX-FGN-01
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 11 Mar 2026
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Impact of Tracheostomy Decannulation on Pulmonary Function in Adult Patients
- ClinicalTrials.gov ID
- NCT07191509
- Acronym / sponsor ID
- 2025-HXKFZX-FGN-01
- Conditions
- Tracheostomy Decannulation
- Keywords
- Speaking Valve, Pulmonary Function Test, Tracheostomy Tube Occlusion, Tracheostomy Decannulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 2025 (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 single-center prospective study enrolls adult patients with long-term tracheostomy who are ready for tube removal (decannulation). Twenty-four hours before decannulation, each participant will receive three physiologic tests-breathing through the tracheostomy tube, breathing with a one-way speaking valve, and breathing with the tube capped. Standard pulmonary-function and arterial-blood-gas measurements will be taken during each test and again 5 days after the tube is removed. The study compares these methods to identify which pre-decannulation test best predicts safe, successful decannulation and to describe the overall impact of tube removal on respiratory function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) in-patients with a pre-existing tracheostomy who are receiving multidisciplinary rehabilitation care at the Respiratory Rehabilitation Center of Beijing Rehabilitation Hospital, Capital Medical University. All candidates have a stable primary illness, are clinically judged ready for elective decannulation, can tolerate a one-way speaking valve for at least 4 hours, and are able to cooperate with bedside spirometry tests. Both sexes and all underlying diagnoses that required tracheostomy (e.g., neurologic, traumatic, postsurgical or pulmonary conditions) are eligible provided they meet the inclusion/exclusion criteria.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Tracheostomised patient whose primary illness is stable and who is scheduled for elective decannulation in the rehabilitation unit.
- Able to tolerate a one-way speaking valve for ≥ 4 h on the day before planned decannulation.
- Capable of following instructions and completing bedside spirometry.
- Patient (or legally authorised representative) has provided written informed consent.
Key exclusion criteria (6 listed)
- No tracheostomy in place or requirement for re-intubation/re-cannulation after planned decannulation.
- Inability to perform lung-function testing either via the tracheostomy tube or via the mouth/nose (e.g., severe upper-airway obstruction, facial deformity).
- Unstable cardiopulmonary or neurological status that makes spirometry unsafe (e.g., ongoing myocardial ischemia, uncontrolled arrhythmia, severe agitation).
- Any acute condition requiring isolation precautions that preclude study procedures.
- Refusal or inability to sign informed consent.
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 ，Tracheostomy Tube Occlusion ，Tracheostomy Tube VentilationSpeaking Valve: Participants are assessed while breathing through a one-way speaking valve attached to the tracheostomy tube. The valve directs exhaled air through the upper airway, restoring phonation and more closely simulating post-decannulation airflow. The assessment is performed for up to 4 hours to evaluate tolerance and respiratory function prior to tracheostomy tube removal. Tracheostomy Tube Occlusion: Participants undergo a capping trial, in which the tracheostomy tube is completely occluded. During this intervention, patients must breathe entirely through their natural upper airway, which increases airway resistance and tests their ability to tolerate decannulation. The capping trial is conducted for 24-48 hours, with monitoring for signs of intolerance. Tracheostomy Tube Ventilation: This intervention involves assessment of respiratory function while the participant breathes directly through the open tracheostomy tube, representing the baseline state prior to any decannu | Device | – |
Primary outcome
Change in Forced Vital Capacity (FVC) [L]
Time frame: Baseline (Day -1) and Day +5 after decannulation.
FVC is obtained with a calibrated portable spirometer. Three acceptable manoeuvres are performed and the highest value kept. Baseline is recorded on Day -1 while the tracheostomy tube is capped; the same test is repeated on Day +5 during oral breathing after successful decannulation. The endpoint is the mean change (Day +5 minus Day -1) in liters; higher values indicate better respiratory function.
10 secondary outcomes
Change in Forced Expiratory Volume in 1 Second (FEV1) [L]
Time frame: Baseline (Day -1) and Day +5 after decannulation.
Change in FEV1/FVC Ratio [%]
Time frame: Baseline (Day -1) and Day +5 after decannulation.
Change in Tidal Volume (VT) [mL]
Time frame: Baseline (Day -1) and Day +5 after decannulation.
Change in Minute Ventilation (VE) [L/min]
Time frame: Baseline (Day -1) and Day +5 after decannulation.
Change in Maximum Voluntary Ventilation (MVV) [L/min]
Time frame: Baseline (Day -1) and Day +5 after decannulation.
Change in Breathing Frequency (BF) [breaths/min]
Time frame: Baseline (Day -1) and Day +5 after decannulation.
Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂) [mm Hg]
Time frame: Day -1 and Day +5.
Change in Arterial Oxygen Partial Pressure (PaO₂) [mm Hg]
Time frame: Day -1 and Day +5.
Change in Blood pH [unitless]
Time frame: Day -1 and Day +5.
Change in Base Excess (BE) [mmol/L]
Time frame: Day -1 and Day +5.
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 11 Mar 2026.
- 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.
Hongying Jiang study chair
Beijing Rehabilitation Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Decannulation, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. 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?
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 Jia Deng (+8656981423, djlm1028@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Vital Capacity (FVC) [L] (time frame: Baseline (Day -1) and Day +5 after 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 11 Mar 2026.