Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients

May 19, 2026 updated by: Hongying Jiang, MD

Comparison of Speaking Valve Trial and Capping Trial in the Decannulation Process for Stroke Patients: A Randomized, Controlled, Multicenter Study

This study aims to compare the efficacy and safety of the Speaking Valve trial versus the traditional Capping trial as indicators for tracheostomy decannulation in stroke patients. The trial is a prospective, multicenter, randomized, parallel-group, outcomes-assessor-blinded study with an exploratory crossover design.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke survivors may develop disorders of consciousness, dysphagia, and airway dysfunction, with some requiring tracheostomy for prolonged mechanical ventilation or airway protection. Prolonged tracheostomy tube placement can lead to complications such as infection, tracheal stenosis, and communication difficulties. Timely and safe decannulation is crucial for rehabilitation. While the capping trial (typically 48-72 hours) is widely used, the speaking valve offers potential advantages by restoring physiological airflow and facilitating communication. This trial will systematically compare these two methods to provide evidence for optimizing decannulation protocols.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

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 Backup

  • Name: Hongying Jiang
  • Phone Number: 56981555
  • Email: 6jhy@163.com

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100043
        • Recruiting
        • Beijing Rehabilitation Hospital, Capital Medical University
        • Contact:
        • Contact:

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

Description

Inclusion Criteria:

Stroke (ischemic or hemorrhagic) with subsequent tracheostomy. Stable stage of stroke: clinically in the post-acute or sequelae stage, with stable vital signs, resolved cerebral edema, normalized intracranial pressure, no new neurological deficits.

Clinically stable, defined as: ventilator-free for ≥48 hours prior to enrollment; stable vital signs (temperature <38°C, heart rate 60-100 bpm, respiratory rate <20/min, systolic blood pressure 90-160 mmHg); no active severe infection requiring IV antibiotics; no organ failure; partial pressure of Carbon Dioxide(PaCO₂) <60 mmHg.

Peak Cough Flow (PCF) ≥100 L/min. 24-hour subglottic secretion volume <20 ml. Signed informed consent by patient or legal representative.

Exclusion Criteria:

Intolerance to cuff deflation: severe cough, dyspnea, SpO₂ <93% (on supplemental oxygen), or respiratory rate >20/min for >5 minutes.

Severe airway structural abnormalities: tracheal stenosis (>50% lumen occlusion confirmed by Computed Tomography or bronchoscopy), tracheoesophageal fistula.

Life expectancy <2 weeks or planned transfer to a non-participating institution within 2 weeks.

Severe uncontrolled neurological or systemic diseases (e.g., advanced cancer, severe heart failure).

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Speaking Valve Group
Passy-Muir Speaking Valve
Other: Passy-Muir Speaking Valve
Stepwise tolerance assessment: 0.5 hour → 4 hours. Decannulation Criteria: Continuous tolerance for 4 hours with stable vital signs, peripheral capillary oxygen saturation(SpO₂) ≥93% (on room air or low-flow oxygen), no significant respiratory distress. If patients in the Capping Group group cannot tolerate continuous catheter occlusion for 48 hours, they are transferred to the Speaking Valve group and undergo a 4-hour voice valve test starting at 0.5 hours.
Active Comparator: Capping Group
Tracheostomy tube capping
Other: Tracheostomy tube capping
Gradual capping: 1hour → 48hours. Decannulation Criteria: Continuous tolerance for 48 hours with stable vital signs, SpO₂ ≥93% (on room air or low-flow oxygen), no significant respiratory distress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decannulation Success Rate
Time Frame: 48 hours post-decannulation
Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants.
48 hours post-decannulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Decannulation
Time Frame: From randomization to decannulation, assessed up to 30 days
Number of days from randomization to successful decannulation.
From randomization to decannulation, assessed up to 30 days
Pneumonia Incidence at 30 Days
Time Frame: 30 days post-decannulation
Proportion of decannulated participants diagnosed with pneumonia within 30 days
30 days post-decannulation
Reintubation Rate at 90 Days
Time Frame: 90 days post-decannulation
Proportion of participants requiring reintubation within 90 days
90 days post-decannulation
Mortality Rate at 90 Days
Time Frame: 90 days post-decannulation
All-cause mortality within 90 days
90 days post-decannulation

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, Capital Medical University

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 (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

August 15, 2027

Study Registration Dates

First Submitted

February 21, 2026

First Submitted That Met QC Criteria

February 21, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-hx-SPEAK-CAP Stroke

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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