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

June 22, 2026 updated by: Hongying Jiang, MD

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Rehabilitation Hospital, Capital Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100043
        • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Condition: Prolonged Disorders of Consciousness (PDOC >28 days) Population: Tracheostomized adults in rehabilitation hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Decannulation Cohort
Patients who pass decannulation protocol
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
Not-decannulation Cohort
Patients failing at any protocol stage
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decannulation rate
Time Frame: At decannulation protocol
Proportion passing full protocol
At decannulation protocol
Decannulation success rate
Time Frame: At 48 hours post decannulation
(Decannulation - Decannulation failure ) / Decannulation
At 48 hours post decannulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRS-R change rate
Time Frame: At a week post decannulation
(Post-decannulation - Baseline)/Baseline
At a week post decannulation
Time to decannulation
Time Frame: through study completion, an average of 1 year
Days from referral to decannulation
through study completion, an average of 1 year
Reintubation rate
Time Frame: 3-month follow-up
Unplanned reintubation
3-month follow-up
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hongying Jiang, MD

Collaborators

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

Investigators

  • Study Chair: Hongying Jiang, Beijing Rehabilitation Hospital, Capital Medical University, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

September 4, 2025

First Submitted That Met QC Criteria

September 18, 2025

First Posted (Actual)

September 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-hxkfzx-step-doc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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