Prolonged Disorders of Consciousness, Tracheostomy
Conditions
Keywords
Decannulation, Protocol, Rehabilitation, Prolonged disorders of consciousness, Speaking wave
Brief summary
To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) in rehabilitation hospitals.
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
1. Tracheostomy status 2. The duration of consciousness disorders\> 28 days 3. CRS-R score \>0 and \<17 4. Signed informed consent by legal representative
Exclusion criteria
1. Non-PDOC tracheostomy patients 2. Death within 2 weeks post-referral
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decannulation success rate | At 48 hours post decannulation | (Decannulation - Decannulation failure ) / Total number of enrolled patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coma Recovery Scale-Revised (CRS-R) scores | through study completion, an average of 1 year | 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. |
| CRS-R change rate | At a week post decannulation | (Post-decannulation - Baseline)/Baseline |
| Time to decannulation | through study completion, an average of 1 year | Days from referral to decannulation |
| Reintubation rate | 90days follow-up | Unplanned reintubation |
Countries
China
Contacts
Beijing Rehabilitation Hospital, Capital Medical University, Beijing