Standardized Tracheostomy Decannulation Protocol for Patients With Prolonged Disorders of Consciousness (STEP-DoC)

Hongying Jiang

Status: Not yet enrolling

Conditions: Prolonged Disorders of Consciousness; Tracheostomy

Treatments: Diagnostic Test: decannulation protocol

Study type: Observational

Funder types: Other

Identifiers

NCT07183670

2025-hxkfzx-step-doc

Details and patient eligibility

About

To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) in rehabilitation hospitals.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. CRS-R score >0
2. Signed informed consent by legal representative

Exclusion criteria

1. Non-PDOC tracheostomy patients
2. Death within 2 weeks post-referral
3. Active respiratory infection

Trial design

300 participants in 2 patient groups

Decannulation Cohort

Description:

Patients who pass decannulation protocol

Treatment:

Diagnostic Test: decannulation protocol

Not-decannulation Cohort

Description:

Patients failing at any protocol stage

Treatment:

Diagnostic Test: decannulation protocol