A Voice Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness (STEP-DoC)

July 30, 2026 updated by: Hongying Jiang, MD

Application of a Voice Valve-Based Decannulation Protocol in Tracheostomized Patients With a 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decannulation success rate
Time Frame: At 48 hours post decannulation
(Decannulation - Decannulation failure ) / Total number of enrolled patients
At 48 hours post decannulation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Reintubation rate
Time Frame: 90days follow-up
Unplanned reintubation
90days follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hongying Jiang, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Tiantan Hospital
People's Hospital of Zhengzhou University
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Hunan Provincial Rehabilitation Hospital
Beijing Rehabilitation Hospital of Capital Medical University
Fengtai Rehabilitation Hospital of Beijing Municipality
Anhui Wanbei Rehabilitation Hospital
The Second People's Hospital of Beihai

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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