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Enrolling by invitation NCT07183670

A Voice Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness

— Observational Prolonged Disorders of Consciousness Tracheostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: decannulation protocol.
Who it may be relevant to
Registry conditions: Prolonged Disorders of Consciousness, Tracheostomy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Application of a Voice Valve-Based Decannulation Protocol in Tracheostomized Patients With a Prolonged Disorders of Consciousness: A Prospective Multicenter Cohort Study

Overview

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

  • Diagnostic test decannulation protocol
    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

Primary outcome measures

  • Decannulation success rate [Time frame: At 48 hours post decannulation]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • Tracheostomy status
  • The duration of consciousness disorders> 28 days
  • CRS-R score >0 and <17
  • Signed informed consent by legal representative

Exclusion criteria

  • Non-PDOC tracheostomy patients
  • Death within 2 weeks post-referral

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China — Beijing
  • Beijing Rehabilitation Hospital, Capital Medical University — Beijing

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. PMID 32428445
  • 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. PMID 38734048
  • 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. PMID 35842715

Identifiers

NCT: NCT07183670 · 2025-hxkfzx-step-doc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗