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| Name | Class |
|---|---|
| Beijing Rehabilitation Hospital | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Hunan Provincial Rehabilitation Hospital | UNKNOWN |
| Beijing Fengtai Rehabilitation Hospital |
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To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) in rehabilitation hospitals.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decannulation Cohort | Patients who pass decannulation protocol |
| |
| Not-decannulation Cohort | Patients failing at any protocol stage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| decannulation protocol | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Decannulation rate | Proportion passing full protocol | At decannulation protocol |
| Decannulation success rate | (Decannulation - Decannulation failure ) / Decannulation | At 48 hours post decannulation |
| Measure | Description | Time Frame |
|---|---|---|
| CRS-R change rate | (Post-decannulation - Baseline)/Baseline | At a week post decannulation |
| Time to decannulation | Days from referral to decannulation |
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Inclusion Criteria:
Exclusion Criteria:
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Condition: Prolonged Disorders of Consciousness (PDOC >28 days) Population: Tracheostomized adults in rehabilitation hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Hongying Jiang | Beijing Rehabilitation Hospital, Capital Medical University, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China | Beijing | Beijing Municipality | 100043 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32428445 | Background | 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. | |
| 38734048 | Background | Draghi 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. |
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| UNKNOWN |
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Samples without DNA
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| through study completion, an average of 1 year |
| Reintubation rate | Unplanned reintubation | 3-month follow-up |
| 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. | through study completion, an average of 1 year |
| Beijing Rehabilitation Hospital, Capital Medical University |
| Beijing |
| China |
| 35842715 | Background | Zhou 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. |