Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT07173634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decannulation rate', 'timeFrame': 'At decannulation', 'description': 'Proportion passing full protocol'}, {'measure': 'Decannulation success rate', 'timeFrame': 'At 48 h post decannulation', 'description': '(Decannulation - Decannulation failure ) / Decannulation'}], 'secondaryOutcomes': [{'measure': 'Time to decannulation', 'timeFrame': '1year', 'description': 'Days from randomization to successful tube removal'}, {'measure': 'Hospital stay duration', 'timeFrame': 'Up to 6 months', 'description': 'Days from randomization to discharge without tracheostomy care'}, {'measure': 'CRS-R change rate', 'timeFrame': '3 months', 'description': '(Post-decannulation score - Baseline)/Baseline'}, {'measure': 'Airway safety score1', 'timeFrame': '48h post-decannulation', 'description': 'Pulse oxygen saturation (SpO₂) fluctuation, minimum value0%, maximum value 100%, the larger the value, the better the result'}, {'measure': 'Airway safety score 2', 'timeFrame': '48h post-decannulation', 'description': 'Blood carbon dioxide partial pressure (pCO₂) , normal range 35-45mmHg. Within the normal range it is good, the greater the deviation from the normal range, the worse the result the larger the value, the better the result.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prolonged disorders of consciousness', 'Decannulation', 'Speaking wave', 'Capping', 'Rehabilitation'], 'conditions': ['Prolonged Disorders of Consciousness']}, 'descriptionModule': {'briefSummary': 'To assess whether the speaking valve trial, when employed as an indicator for extubation during the removal of tracheostomy tubes in patients with chronic consciousness disorder, provides superior benefits and heightened sensitivity relative to the conventional capping trial, thereby enhancing the overall extubation process.', 'detailedDescription': 'Patients with chronic consciousness disorder who require long-term mechanical ventilation and airway protection commonly undergo tracheostomy. However, tracheostomy tubes can cause inflammation, stenosis, excessive coughing, and swallowing dysfunction. Removing the tracheostomy tube, or extubation, can prevent long-term complications such as tracheal stenosis, tracheomalacia, vocal cord injury, and accidental extubation. Additionally, it enhances patient comfort, appearance, swallowing function, communication ability, and social integration. Therefore, for clinically stable patients with chronic consciousness disorder who can breathe spontaneously, have effective cough reflexes, and are capable of protecting their airways, early tube removal is advisable.In current extubation protocols, the capping trial is predominantly used to assess whether patients can tolerate tracheostomy tube removal. There have also been reports of studies using speaking valves as an alternative to the capping trial, but no direct comparison has been made between the two methods. Patients who can tolerate capping for 24 hours are generally considered suitable for tracheostomy tube removal. A speaking valve is a one-way valve placed at the end of the tracheostomy tube that directs airflow to the upper airway when the cuff is deflated. Studies have found that patients undergoing speaking valve training benefit in terms of vital signs, airway secretions, sense of smell, weaning from mechanical ventilation, post-tracheostomy extubation, hospital stay duration, and quality of life. However, it remains unclear whether this method can improve the success rate of extubation assessment in patients with chronic consciousness disorder. This study compares speaking valve training and the traditional capping trial in post-tracheostomy patients with chronic consciousness disorder, evaluating differences in extubation tolerance, extubation success rate, time to extubation, hospital stay duration, and improvement in consciousness levels.\n\nParazacco spilurus subsp. spilurus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (18-80 years) with tracheostomy\n2. Prolonged DoC (\\>28 days) confirmed by CRS-R score \\>0\n3. Ventilator-free \\>48h\n4. PaCO₂ \\<60 mmHg\n5. PCF ≥100 L/min\n6. No sepsis/organ failure\n7. Controlled pulmonary infection\n8. Written informed consent by legal representative\n\nExclusion Criteria:\n\n1. Intolerance to cuff deflation:\n2. SpO₂ \\<93% on O₂ supplementation OR Respiratory rate \\>20/min for \\>5min\n3. Severe tracheal stenosis (\\>50% lumen occlusion on CT)\n4. Death within 2 weeks post-enrollment\n5. Participation in conflicting interventional trial'}, 'identificationModule': {'nctId': 'NCT07173634', 'acronym': 'SPEAK-CAP', 'briefTitle': 'Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Comparison of Speaking Valve Trial Versus Capping Trial in the Decannulation Process for Patients With Prolonged Disorders of Consciousness: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2025-hxkf-s&tc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Speaking Valve (SV) Group', 'description': 'Stepwise speaking valve tolerance: 0.5h → 1h → 2h → 4h. Decannulation if: Tolerates a 4-hour speaking valve trial with pulse oxygen saturation (SpO₂) ≥ 95%, breathing rate (RR) \\< 20/min, and no signs of distress during the 4-hour trial.', 'interventionNames': ['Other: Speaking Valve Trial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capping Group', 'description': 'Gradual capping: 1 hour → 4 hours → 6 hours → 12 hours → 24 hours → 48 hours. Decannulation if: Tolerates 48 hours of capping with SpO₂ ≥95%, respiratory rate (RR) \\<20/min, and no distress during the 48-hour trial.', 'interventionNames': ['Other: Capping Trial']}], 'interventions': [{'name': 'Speaking Valve Trial', 'type': 'OTHER', 'description': "The speaking valve group ascertains a patient's eligibility for decannulation following the results of the speaking valve test. A patient who can endure a 4-hour trial with a speaking valve, maintaining a pulse oxygen saturation (SpO₂) of at least 95%, a breathing rate (RR) below 20 per minute, and exhibiting no signs of distress throughout the trial, qualifies for decannulation.", 'armGroupLabels': ['Speaking Valve (SV) Group']}, {'name': 'Capping Trial', 'type': 'OTHER', 'description': "The capping valve group determines a patient's eligibility for decannulation based on the results of the capping test. A patient who can tolerate 48 hours of capping with a pulse oxygen saturation (SpO₂) of ≥95%, a breathing rate (RR) of \\<20/min, and no signs of distress during the 48-hour trial, is eligible for decannulation.", 'armGroupLabels': ['Capping Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Qian Feng', 'role': 'CONTACT', 'email': 'fengqian0263@163.com', 'phone': '17207122873'}, {'name': 'Hongying Jiang', 'role': 'CONTACT', 'email': '6jhy@163.com', 'phone': '+8656981555'}], 'overallOfficials': [{'name': 'Hongying Jiang', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Rehabilitation Hospital, Capital Medical University, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hongying Jiang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Rehabilitation Hospital', 'class': 'OTHER'}, {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hongying Jiang', 'investigatorAffiliation': 'Capital Medical University'}}}}