Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07183670

Standardized Tracheostomy Decannulation Protocol for Patients With Prolonged Disorders of Consciousness

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CRS-R score >0
  • Signed informed consent by legal representative

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Decannulation rate

    Time frame: At decannulation protocol

    Proportion passing full protocol

  2. Decannulation success rate

    Time frame: At 48 hours post decannulation

    (Decannulation - Decannulation failure ) / Decannulation

Secondary outcomes

  1. CRS-R change rate

    Time frame: At a week post decannulation

    (Post-decannulation - Baseline)/Baseline

  2. Time to decannulation

    Time frame: through study completion, an average of 1 year

    Days from referral to decannulation

  3. Reintubation rate

    Time frame: 3-month follow-up

    Unplanned reintubation

  4. Coma Recovery Scale-Revised (CRS-R) scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hongying Jiang, MD

Other

Collaborators

  • Beijing Fengtai Rehabilitation Hospital
  • Beijing Rehabilitation Hospital
  • Beijing Tiantan Hospital
  • Hunan Provincial Rehabilitation Hospital

Registry information

Official study title

Standardized Tracheostomy Decannulation Protocol for Patients With Prolonged Disorders of Consciousness: A Prospective Multicenter Cohort Study

Acronym: STEP-DoC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.