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

NCT07435727 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Beijing Rehabilitation Hospital

    collaborator OTHER

  • Hunan Provincial Rehabilitation Hospital

    collaborator UNKNOWN

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Beijing Fengtai Rehabilitation Hospital

    collaborator UNKNOWN

  • Hongying Jiang, MD

    lead OTHER

Principal Investigators

  • Hongying Jiang · Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2027-05-15
Completion
2027-08-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435727 on ClinicalTrials.gov