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

NCT07435727 | Recruiting DMC

• 1 other identifier: 2026-hx-SPEAK-CAP Stroke
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Decannulation Success Rate

  Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants.

  48 hours post-decannulation

Secondary Outcomes (4)

• Time to Decannulation

  From randomization to decannulation, assessed up to 30 days

• Pneumonia Incidence at 30 Days

  30 days post-decannulation

• Reintubation Rate at 90 Days

  90 days post-decannulation

• Mortality Rate at 90 Days

  90 days post-decannulation

Study Arms (2)

Speaking Valve Group

EXPERIMENTAL

Passy-Muir Speaking Valve

Other: Passy-Muir Speaking Valve

Capping Group

ACTIVE COMPARATOR

Tracheostomy tube capping

Other: Tracheostomy tube capping

Interventions

Passy-Muir Speaking Valve OTHER

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.

Speaking Valve Group

Tracheostomy tube capping OTHER

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.

Capping Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hongying Jiang, MD: lead
• Beijing Rehabilitation Hospital: collaborator
• Hunan Provincial Rehabilitation Hospital: collaborator
• Beijing Tiantan Hospital: collaborator
• Beijing Fengtai Rehabilitation Hospital: collaborator

Study Sites (1)

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, Beijing Municipality, 100043, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Tracheostomy Decannulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tracheostomy; Airway Management; Therapeutics; Device Removal; Surgical Procedures, Operative; Ostomy; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Hongying Jiang

  Capital Medical University

  STUDY CHAIR

Central Study Contacts

Qian Feng

CONTACT

17207122873; fengqian0263@163.com

Hongying Jiang

CONTACT

56981555; 6jhy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)