Health TrialsbyHealthPanel

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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHongying Jiang, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Passy-Muir Speaking Valve

    Other intervention

    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.

  • Tracheostomy tube capping

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Speaking Valve GroupExperimental treatment 1 intervention
Group B: Capping GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Decannulation Success Rate

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

Time frame
48 hours post-decannulation

Secondary outcomes

1

Time to Decannulation

Number of days from randomization to successful decannulation.

Time frame
From randomization to decannulation, assessed up to 30 days
2

Pneumonia Incidence at 30 Days

Proportion of decannulated participants diagnosed with pneumonia within 30 days

Time frame
30 days post-decannulation
3

Reintubation Rate at 90 Days

Proportion of participants requiring reintubation within 90 days

Time frame
90 days post-decannulation
4

Mortality Rate at 90 Days

All-cause mortality within 90 days

Time frame
90 days post-decannulation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hongying Jiang, MD

Lead sponsor

Capital Medical University

Sponsor institution

Beijing Rehabilitation Hospital

Collaborator

Hunan Provincial Rehabilitation Hospital

Collaborator

Beijing Tiantan Hospital

Collaborator

Beijing Fengtai Rehabilitation Hospital

Collaborator

Source ClinicalTrials.gov
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