Prolonged Disorders of ConsciousnessSPEAK-CAPNCT07173634
Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness
A study testing Speaking Valve Trial and Capping Trial in people with Prolonged Disorders of Consciousness, run by Hongying Jiang, MD at 1 site in China.
Trial summary
To assess whether the speaking valve trial, when employed as an indicator for extubation during the removal of tracheostomy tubes in patients with chronic consciousness disorder, provides superior benefits and heightened sensitivity relative to the conventional capping trial, thereby enhancing the overall extubation… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prolonged Disorders of Consciousness
- What is being tested?
- Speaking Valve Trial and Capping Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 May 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18-80 years) with tracheostomy
- Prolonged DoC (>28 days) confirmed by CRS-R score >0
- Ventilator-free >48h
- PaCO₂ <60 mmHg
- PCF ≥100 L/min
- No sepsis/organ failure
- Controlled pulmonary infection
- Written informed consent by legal representative
Who cannot join
- Intolerance to cuff deflation:
- SpO₂ <93% on O₂ supplementation OR Respiratory rate >20/min for >5min
- Severe tracheal stenosis (>50% lumen occlusion on CT)
- Death within 2 weeks post-enrollment
- Participation in conflicting interventional trial
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
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043
About this study
Official title: Comparison of Speaking Valve Trial Versus Capping Trial in the Decannulation Process for Patients With Prolonged Disorders of Consciousness: A Randomized Controlled Study
To assess whether the speaking valve trial, when employed as an indicator for extubation during the removal of tracheostomy tubes in patients with chronic consciousness disorder, provides superior benefits and heightened sensitivity relative to the conventional capping trial, thereby enhancing the overall extubation process.
Read the detailed description
Patients with chronic consciousness disorder who require long-term mechanical ventilation and airway protection commonly undergo tracheostomy. However, tracheostomy tubes can cause inflammation, stenosis, excessive coughing, and swallowing dysfunction. Removing the tracheostomy tube, or extubation, can prevent long-term complications such as tracheal stenosis, tracheomalacia, vocal cord injury, and accidental extubation. Additionally, it enhances patient comfort, appearance, swallowing function, communication ability, and social integration. Therefore, for clinically stable patients with chronic consciousness disorder who can breathe spontaneously, have effective cough reflexes, and are capable of protecting their airways, early tube removal is advisable.In current extubation protocols, the capping trial is predominantly used to assess whether patients can tolerate tracheostomy tube removal. There have also been reports of studies using speaking valves as an alternative to the capping trial, but no direct comparison has been made between the two methods. Patients who can tolerate capping for 24 hours are generally considered suitable for tracheostomy tube removal. A 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. Studies have found that patients undergoing speaking valve training benefit in terms of vital signs, airway secretions, sense of smell, weaning from mechanical ventilation, post-tracheostomy extubation, hospital stay duration, and quality of life. However, it remains unclear whether this method can improve the success rate of extubation assessment in patients with chronic consciousness disorder. This study compares speaking valve training and the traditional capping trial in post-tracheostomy patients with chronic consciousness disorder, evaluating differences in extubation tolerance, extubation success rate, time to extubation, hospital stay duration, and improvement in consciousness levels.
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- Conditions
- Prolonged Disorders of Consciousness
- Being tested
- Speaking Valve Trial, Capping Trial
- Keywords
- Prolonged disorders of consciousness, Decannulation, Speaking wave, Capping, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speaking Valve TrialOther
The speaking valve group ascertains a patient's eligibility for decannulation following the results of the speaking valve test. A patient who can endure a 4-hour trial with a speaking valve, maintaining a pulse oxygen saturation (SpO₂) of at least 95%, a breathing rate (RR) below 20 per minute, and exhibiting no signs of distress throughout the trial, qualifies for decannulation.
Capping TrialOther
The capping valve group determines a patient's eligibility for decannulation based on the results of the capping test. A patient who can tolerate 48 hours of capping with a pulse oxygen saturation (SpO₂) of ≥95%, a breathing rate (RR) of <20/min, and no signs of distress during the 48-hour trial, is eligible for decannulation.
| Study group | Role | What they receive |
|---|---|---|
| Speaking Valve (SV) Group | Experimental | Stepwise speaking valve tolerance: 0.5h → 1h → 2h → 4h. Decannulation if: Tolerates a 4-hour speaking valve trial with pulse oxygen saturation (SpO₂) ≥ 95%, breathing rate (RR) < 20/min, and no signs of distress during the 4-hour trial. Receives: Other: Speaking Valve Trial |
| Capping Group | Active comparator | Gradual capping: 1 hour → 4 hours → 6 hours → 12 hours → 24 hours → 48 hours. Decannulation if: Tolerates 48 hours of capping with SpO₂ ≥95%, respiratory rate (RR) <20/min, and no distress during the 48-hour trial. Receives: Other: Capping Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decannulation rate
Proportion passing full protocol
Measured: At decannulation
Decannulation success rate
(Decannulation - Decannulation failure ) / Decannulation
Measured: At 48 h post decannulation
Secondary outcomes (5)
Time to decannulation
Days from randomization to successful tube removal
Measured: 1year
Hospital stay duration
Days from randomization to discharge without tracheostomy care
Measured: Up to 6 months
CRS-R change rate
(Post-decannulation score - Baseline)/Baseline
Measured: 3 months
Airway safety score1
Pulse oxygen saturation (SpO₂) fluctuation, minimum value0%, maximum value 100%, the larger the value, the better the result
Measured: 48h post-decannulation
Airway safety score 2
Blood carbon dioxide partial pressure (pCO₂) , normal range 35-45mmHg. Within the normal range it is good, the greater the deviation from the normal range, the worse the result the larger the value, the better the result.
Measured: 48h post-decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Disorders of ConsciousnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongying Jiang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Beijing Tiantan Hospital, Hunan Provincial Rehabilitation Hospital, Beijing Fengtai Rehabilitation Hospital
- Responsible party
- Sponsor-investigator, Hongying Jiang, MD, Capital Medical University
- Investigators
- Hongying Jiang, Study chair, Beijing Rehabilitation Hospital, Capital Medical University, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173634
- Sponsor's protocol ID
- 2025-hxkf-s&tc
- Acronym
- SPEAK-CAP
- Status last verified
- May 2026
- First submitted
- 4 Sep 2025
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Speaking Valve Trial Versus Capping Trial in the Decannulation Process for Patients With Prolonged Disorders of Consciousness: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07173634
- Acronym / sponsor ID
- SPEAK-CAP / 2025-hxkf-s&tc
- Conditions
- Prolonged Disorders of Consciousness
- Keywords
- Prolonged disorders of consciousness, Decannulation, Speaking wave, Capping, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hongying Jiang, MDUniversity, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Beijing Tiantan Hospital, Hunan Provincial Rehabilitation Hospital, Beijing Fengtai Rehabilitation Hospital
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 15 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.
To assess whether the speaking valve trial, when employed as an indicator for extubation during the removal of tracheostomy tubes in patients with chronic consciousness disorder, provides superior benefits and heightened sensitivity relative to the conventional capping trial, thereby enhancing the overall extubation process.
Detailed description
Patients with chronic consciousness disorder who require long-term mechanical ventilation and airway protection commonly undergo tracheostomy. However, tracheostomy tubes can cause inflammation, stenosis, excessive coughing, and swallowing dysfunction. Removing the tracheostomy tube, or extubation, can prevent long-term complications such as tracheal stenosis, tracheomalacia, vocal cord injury, and accidental extubation. Additionally, it enhances patient comfort, appearance, swallowing function, communication ability, and social integration. Therefore, for clinically stable patients with chronic consciousness disorder who can breathe spontaneously, have effective cough reflexes, and are capable of protecting their airways, early tube removal is advisable.In current extubation protocols, the capping trial is predominantly used to assess whether patients can tolerate tracheostomy tube removal. There have also been reports of studies using speaking valves as an alternative to the capping trial, but no direct comparison has been made between the two methods. Patients who can tolerate capping for 24 hours are generally considered suitable for tracheostomy tube removal. A 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. Studies have found that patients undergoing speaking valve training benefit in terms of vital signs, airway secretions, sense of smell, weaning from mechanical ventilation, post-tracheostomy extubation, hospital stay duration, and quality of life. However, it remains unclear whether this method can improve the success rate of extubation assessment in patients with chronic consciousness disorder. This study compares speaking valve training and the traditional capping trial in post-tracheostomy patients with chronic consciousness disorder, evaluating differences in extubation tolerance, extubation success rate, time to extubation, hospital stay duration, and improvement in consciousness levels.
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Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speaking Valve (SV) Group | Experimental | Other: Speaking Valve TrialStepwise speaking valve tolerance: 0.5h → 1h → 2h → 4h. Decannulation if: Tolerates a 4-hour speaking valve trial with pulse oxygen saturation (SpO₂) ≥ 95%, breathing rate (RR) < 20/min, and no signs of distress during the 4-hour trial. |
| Capping Group | Active comparator | Other: Capping TrialGradual capping: 1 hour → 4 hours → 6 hours → 12 hours → 24 hours → 48 hours. Decannulation if: Tolerates 48 hours of capping with SpO₂ ≥95%, respiratory rate (RR) <20/min, and no distress during the 48-hour trial. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults (18-80 years) with tracheostomy
- Prolonged DoC (>28 days) confirmed by CRS-R score >0
- Ventilator-free >48h
- PaCO₂ <60 mmHg
- PCF ≥100 L/min
Key exclusion criteria (5 listed)
- Intolerance to cuff deflation:
- SpO₂ <93% on O₂ supplementation OR Respiratory rate >20/min for >5min
- Severe tracheal stenosis (>50% lumen occlusion on CT)
- Death within 2 weeks post-enrollment
- Participation in conflicting interventional trial
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 TrialThe speaking valve group ascertains a patient's eligibility for decannulation following the results of the speaking valve test. A patient who can endure a 4-hour trial with a speaking valve, maintaining a pulse oxygen saturation (SpO₂) of at least 95%, a breathing rate (RR) below 20 per minute, and exhibiting no signs of distress throughout the trial, qualifies for decannulation. | Other | Speaking Valve (SV) Group |
| Capping TrialThe capping valve group determines a patient's eligibility for decannulation based on the results of the capping test. A patient who can tolerate 48 hours of capping with a pulse oxygen saturation (SpO₂) of ≥95%, a breathing rate (RR) of <20/min, and no signs of distress during the 48-hour trial, is eligible for decannulation. | Other | Capping Group |
Primary outcome
Decannulation rate
Time frame: At decannulation
Proportion passing full protocol
Decannulation success rate
Time frame: At 48 h post decannulation
(Decannulation - Decannulation failure ) / Decannulation
5 secondary outcomes
Time to decannulation
Time frame: 1year
Hospital stay duration
Time frame: Up to 6 months
CRS-R change rate
Time frame: 3 months
Airway safety score1
Time frame: 48h post-decannulation
Airway safety score 2
Time frame: 48h post-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 22 May 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, Capital Medical University, Beijing
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 Trial and Capping Trial in people with Prolonged Disorders of Consciousness, run by Hongying Jiang, MD 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 8 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: enrolling by invitation, as of the sponsor's last update on 22 May 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?
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?
Decannulation rate (time frame: At decannulation). The study lists 2 primary outcomes in all. 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 22 May 2026.