Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 8:57 PM
Study NCT ID:
NCT07435727
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098522', 'term': 'Tracheostomy Decannulation'}], 'ancestors': [{'id': 'D014139', 'term': 'Tracheostomy'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020878', 'term': 'Device Removal'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-21', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decannulation Success Rate', 'timeFrame': '48 hours post-decannulation', 'description': 'Proportion of participants with successful decannulation and no reintubation within 48 hours, based on total randomized participants.'}], 'secondaryOutcomes': [{'measure': 'Time to Decannulation', 'timeFrame': 'From randomization to decannulation, assessed up to 30 days', 'description': 'Number of days from randomization to successful decannulation.'}, {'measure': 'Pneumonia Incidence at 30 Days', 'timeFrame': '30 days post-decannulation', 'description': 'Proportion of decannulated participants diagnosed with pneumonia within 30 days'}, {'measure': 'Reintubation Rate at 90 Days', 'timeFrame': '90 days post-decannulation', 'description': 'Proportion of participants requiring reintubation within 90 days'}, {'measure': 'Mortality Rate at 90 Days', 'timeFrame': '90 days post-decannulation', 'description': 'All-cause mortality within 90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStroke (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.\n\nClinically 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 BP 90-160 mmHg); no active severe infection requiring IV antibiotics; no organ failure; PaCO₂ \\<60 mmHg.\n\nPeak Cough Flow (PCF) ≥100 L/min. 24-hour subglottic secretion volume \\<20 ml. Signed informed consent by patient or legal representative.\n\nExclusion Criteria:\n\nIntolerance to cuff deflation: severe cough, dyspnea, SpO₂ \\<93% (on supplemental oxygen), or respiratory rate \\>20/min for \\>5 minutes.\n\nSevere airway structural abnormalities: tracheal stenosis (\\>50% lumen occlusion confirmed by CT or bronchoscopy), tracheoesophageal fistula.\n\nLife expectancy \\<2 weeks or planned transfer to a non-participating institution within 2 weeks.\n\nSevere uncontrolled neurological or systemic diseases (e.g., advanced cancer, severe heart failure).'}, 'identificationModule': {'nctId': 'NCT07435727', 'briefTitle': 'Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Comparison of Speaking Valve Trial and Capping Trial in the Decannulation Process for Stroke Patients: A Randomized, Controlled, Multicenter Study', 'orgStudyIdInfo': {'id': '2026-hx-SPEAK-CAP Stroke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Speaking Valve Group', 'description': 'Passy-Muir Speaking Valve', 'interventionNames': ['Other: Passy-Muir Speaking Valve']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capping Group', 'description': 'Tracheostomy tube capping', 'interventionNames': ['Other: Tracheostomy tube capping']}], 'interventions': [{'name': 'Passy-Muir Speaking Valve', 'type': 'OTHER', 'description': 'Stepwise tolerance assessment: 0.5 hour → 4 hours. Decannulation Criteria: Continuous tolerance for 4 hours with stable vital signs, SpO₂ ≥93% (on room air or low-flow oxygen), no significant respiratory distress.', 'armGroupLabels': ['Speaking Valve Group']}, {'name': 'Tracheostomy tube capping', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Capping Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100043', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Qian Feng', 'role': 'CONTACT', 'email': 'fengqian0263@163.com', 'phone': '17207122873'}, {'name': 'Hongying Jiang', 'role': 'CONTACT', 'email': '6jhy@163.com', 'phone': '56981555'}], 'facility': 'Beijing Rehabilitation Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qian Feng', 'role': 'CONTACT', 'email': 'fengqian0263@163.com', 'phone': '17207122873'}, {'name': 'Hongying Jiang', 'role': 'CONTACT', 'email': '6jhy@163.com', 'phone': '56981555'}], 'overallOfficials': [{'name': 'Hongying Jiang', 'role': 'STUDY_CHAIR', 'affiliation': 'Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hongying Jiang, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Rehabilitation Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hongying Jiang, MD', 'investigatorAffiliation': 'Capital Medical University'}}}}