Prolonged Disorders of ConsciousnessSTEP-DoCNCT07183670
A Voice Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
An observational study of Prolonged Disorders of Consciousness and Tracheostomy, run by Hongying Jiang, MD at 2 sites in China.
Trial summary
To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prolonged Disorders of Consciousness, Tracheostomy
- What is being tested?
- decannulation protocol
- How many people
- 184 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2026to 1 May 2027
- How long will I take part?
- 3 Months
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Condition: Prolonged Disorders of Consciousness (DOC >28 days) Population: Tracheostomized adults in hospitals
Who may be able to join
- Tracheostomy status
- The duration of consciousness disorders> 28 days
- CRS-R score >0 and <17
- Signed informed consent by legal representative
Who cannot join
- Non-PDOC tracheostomy patients
- Death within 2 weeks post-referral
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043
Beijing Rehabilitation Hospital, Capital Medical University
Beijing
About this study
Official title: Application of a Voice Valve-Based Decannulation Protocol in Tracheostomized Patients With a Prolonged Disorders of Consciousness: A Prospective Multicenter Cohort Study
To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) .
Read the detailed description
Advances in critical care have significantly increased the number of survivors with severe acquired brain injury (sABI). A subset of these patients develops Disorders of Consciousness (DoC), defined as prolonged DoC (pDoC) when lasting >28 days. Tracheostomy is often indicated for long-term mechanical ventilation and airway protection. However, tracheostomy tubes may cause inflammation, stenosis, excessive coughing, and dysphagia. Decannulation improves patient comfort, appearance, swallowing, communication, and social reintegration, while reducing long-term complications (e.g., tracheal stenosis, malacia, vocal cord injury, accidental decannulation) . Despite these benefits, consensus on safety and optimal timing for decannulation in pDoC remains elusive due to uncertain airway protection and aspiration risks. Our center previously demonstrated that a standardized decannulation protocol implemented by a pulmonary rehabilitation team correlates with successful decannulation. Key innovations include: (1) Replacing capping trials with 4-hour continuous tolerance of a speaking valve (reducing airway resistance and delayed decannulation ); (2) Not considering dysphagia a contraindication if patients manage secretions effectively and retain cough strength, even if requiring enteral nutrition (nasogastric/jejunal tubes or PEG) . This multicenter study aims to validate this protocol in pDoC patients and assess changes in consciousness levels pre-/post-decannulation.
- Conditions
- Prolonged Disorders of Consciousness, Tracheostomy
- Being tested
- decannulation protocol
- Keywords
- Decannulation, Protocol, Rehabilitation, Prolonged disorders of consciousness, Speaking wave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decannulation protocolDiagnostic test
Step 1: The patient's clinical stability is confirmed. Step 2: Tolerance to the speaking valve is assessed. Step 3: The wearing time of the speaking valve is extended continuously for 4 h, and no tracheostomy cannula is used for sputum suction within 4 h.
Step 4: Cough strength is evaluated to be good before decannulation. Decannulation Criteria: Pass Step 1 + Step 2 + Step 3 + Step 4
| Study group | Role | What they receive |
|---|---|---|
| Decannulation Cohort | Patients who pass decannulation protocol Receives: Diagnostic Test: decannulation protocol | |
| Not-decannulation Cohort | Patients failing at any protocol stage Receives: Diagnostic Test: decannulation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decannulation success rate
(Decannulation - Decannulation failure ) / Total number of enrolled patients
Measured: At 48 hours post decannulation
Secondary outcomes (4)
Coma Recovery Scale-Revised (CRS-R) scores
Comparison of CRS-R scores between the extubation group and the non-extubation group before extubation, A higher score (0-23) indicates better level of consciousness.
Measured: through study completion, an average of 1 year
CRS-R change rate
(Post-decannulation - Baseline)/Baseline
Measured: At a week post decannulation
Time to decannulation
Days from clinically stable to decannulation
Measured: through study completion, an average of 1 year
Reintubation rate
Unplanned reintubation
Measured: 90days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (estimated)
- Target duration
- 3 Months
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, Fengtai Rehabilitation Hospital of Beijing Municipality, People's Hospital of Zhengzhou University, Hunan Provincial Rehabilitation Hospital, Anhui Wanbei Rehabilitation Hospital, Jiangbin Hospital of Guangxi Zhuang Autonomous Region, The Second People's Hospital of Beihai
- 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
- NCT07183670
- Sponsor's protocol ID
- 2025-hxkfzx-step-doc
- Acronym
- STEP-DoC
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hakiki B, Draghi F, Pancani S, Portaccio E, Grippo A, Binazzi B, Tofani A, Scarpino M, Macchi C, Cecchi F. Decannulation After a Severe Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Nov;101(11):1906-1913. doi: 10.1016/j.apmr.2020.05.004. Epub 2020 May 16.
PubMed 32428445Draghi F, Pancani S, De Nisco A, Romoli AM, Maccanti D, Burali R, Grippo A, Macchi C, Cecchi F, Hakiki B. Implications of the Consciousness State on Decannulation in Patients With a Prolonged Disorder of Consciousness. Arch Phys Med Rehabil. 2024 Sep;105(9):1691-1699. doi: 10.1016/j.apmr.2024.05.006. Epub 2024 May 10.
PubMed 38734048Zhou T, Wang J, Zhang C, Zhang B, Guo H, Yang B, Li Q, Ge J, Li Y, Niu G, Gao H, Jiang H. Tracheostomy decannulation protocol in patients with prolonged tracheostomy referred to a rehabilitation hospital: a prospective cohort study. J Intensive Care. 2022 Jul 16;10(1):34. doi: 10.1186/s40560-022-00626-3.
PubMed 35842715
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Voice Valve-Based Decannulation Protocol in Tracheostomized Patients With a Prolonged Disorders of Consciousness: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07183670
- Acronym / sponsor ID
- STEP-DoC / 2025-hxkfzx-step-doc
- Conditions
- Prolonged Disorders of Consciousness, Tracheostomy
- Keywords
- Decannulation, Protocol, Rehabilitation, Prolonged disorders of consciousness, Speaking wave
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Hongying Jiang, MDUniversity, hospital or other
- Collaborators
- Beijing Rehabilitation Hospital of Capital Medical University, Beijing Tiantan Hospital, Fengtai Rehabilitation Hospital of Beijing Municipality, People's Hospital of Zhengzhou University, Hunan Provincial Rehabilitation Hospital, Anhui Wanbei Rehabilitation Hospital, Jiangbin Hospital of Guangxi Zhuang Autonomous Region, The Second People's Hospital of Beihai
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 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 evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) .
Detailed description
Advances in critical care have significantly increased the number of survivors with severe acquired brain injury (sABI). A subset of these patients develops Disorders of Consciousness (DoC), defined as prolonged DoC (pDoC) when lasting >28 days. Tracheostomy is often indicated for long-term mechanical ventilation and airway protection. However, tracheostomy tubes may cause inflammation, stenosis, excessive coughing, and dysphagia. Decannulation improves patient comfort, appearance, swallowing, communication, and social reintegration, while reducing long-term complications (e.g., tracheal stenosis, malacia, vocal cord injury, accidental decannulation) . Despite these benefits, consensus on safety and optimal timing for decannulation in pDoC remains elusive due to uncertain airway protection and aspiration risks. Our center previously demonstrated that a standardized decannulation protocol implemented by a pulmonary rehabilitation team correlates with successful decannulation. Key innovations include: (1) Replacing capping trials with 4-hour continuous tolerance of a speaking valve (reducing airway resistance and delayed decannulation ); (2) Not considering dysphagia a contraindication if patients manage secretions effectively and retain cough strength, even if requiring enteral nutrition (nasogastric/jejunal tubes or PEG) . This multicenter study aims to validate this protocol in pDoC patients and assess changes in consciousness levels pre-/post-decannulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decannulation Cohort | – | Diagnostic Test: decannulation protocolPatients who pass decannulation protocol |
| Not-decannulation Cohort | – | Diagnostic Test: decannulation protocolPatients failing at any protocol stage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Condition: Prolonged Disorders of Consciousness (DOC >28 days) Population: Tracheostomized adults in hospitals
Key inclusion criteria (4 listed)
- Tracheostomy status
- The duration of consciousness disorders> 28 days
- CRS-R score >0 and <17
- Signed informed consent by legal representative
Key exclusion criteria (2 listed)
- Non-PDOC tracheostomy patients
- Death within 2 weeks post-referral
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 |
|---|---|---|
| decannulation protocolStep 1: The patient's clinical stability is confirmed. Step 2: Tolerance to the speaking valve is assessed. Step 3: The wearing time of the speaking valve is extended continuously for 4 h, and no tracheostomy cannula is used for sputum suction within 4 h. Step 4: Cough strength is evaluated to be good before decannulation. Decannulation Criteria: Pass Step 1 + Step 2 + Step 3 + Step 4 | Diagnostic test | Decannulation Cohort, Not-decannulation Cohort |
Primary outcome
Decannulation success rate
Time frame: At 48 hours post decannulation
(Decannulation - Decannulation failure ) / Total number of enrolled patients
4 secondary outcomes
Coma Recovery Scale-Revised (CRS-R) scores
Time frame: through study completion, an average of 1 year
CRS-R change rate
Time frame: At a week post decannulation
Time to decannulation
Time frame: through study completion, an average of 1 year
Reintubation rate
Time frame: 90days follow-up
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 19 Oct 2026.
- Background: PubMed 32428445Hakiki B, Draghi F, Pancani S, Portaccio E, Grippo A, Binazzi B, Tofani A, Scarpino M, Macchi C, Cecchi F. Decannulation After a Severe Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Nov;101(11):1906-1913. doi: 10.1016/j.apmr.2020.05.004. Epub 2020 May 16.
- Background: PubMed 38734048Draghi F, Pancani S, De Nisco A, Romoli AM, Maccanti D, Burali R, Grippo A, Macchi C, Cecchi F, Hakiki B. Implications of the Consciousness State on Decannulation in Patients With a Prolonged Disorder of Consciousness. Arch Phys Med Rehabil. 2024 Sep;105(9):1691-1699. doi: 10.1016/j.apmr.2024.05.006. Epub 2024 May 10.
- Background: PubMed 35842715Zhou T, Wang J, Zhang C, Zhang B, Guo H, Yang B, Li Q, Ge J, Li Y, Niu G, Gao H, Jiang H. Tracheostomy decannulation protocol in patients with prolonged tracheostomy referred to a rehabilitation hospital: a prospective cohort study. J Intensive Care. 2022 Jul 16;10(1):34. doi: 10.1186/s40560-022-00626-3.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolonged Disorders of Consciousness and Tracheostomy, run by Hongying Jiang, MD at 2 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 2 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 success rate (time frame: At 48 hours post decannulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183670, which also lists 3 linked publications.
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 19 Oct 2026.