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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07183670
Acronym
STEP-DoC
Enrollment
184
Registered
2025-09-19
Start date
2026-02-01
Completion date
2027-05-01
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged Disorders of Consciousness, Tracheostomy

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

DIAGNOSTIC_TESTdecannulation 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

Sponsors

Hongying Jiang, MD
Lead SponsorOTHER
Beijing Rehabilitation Hospital of Capital Medical University
CollaboratorOTHER
Beijing Tiantan Hospital
CollaboratorOTHER
Fengtai Rehabilitation Hospital of Beijing Municipality
CollaboratorUNKNOWN
People's Hospital of Zhengzhou University
CollaboratorOTHER
Hunan Provincial Rehabilitation Hospital
CollaboratorOTHER
Anhui Wanbei Rehabilitation Hospital
CollaboratorUNKNOWN
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
CollaboratorUNKNOWN
The Second People's Hospital of Beihai
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Decannulation success rateAt 48 hours post decannulation(Decannulation - Decannulation failure ) / Total number of enrolled patients

Secondary

MeasureTime frameDescription
Coma Recovery Scale-Revised (CRS-R) scoresthrough study completion, an average of 1 yearComparison 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 rateAt a week post decannulation(Post-decannulation - Baseline)/Baseline
Time to decannulationthrough study completion, an average of 1 yearDays from referral to decannulation
Reintubation rate90days follow-upUnplanned reintubation

Countries

China

Contacts

STUDY_CHAIRHongying Jiang

Beijing Rehabilitation Hospital, Capital Medical University, Beijing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026