[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593373":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":36,"locations":35,"responsibleParty":42,"collaborators":35,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":35,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":35,"enrollmentInfo":53,"targetDuration":35,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":69,"whyStopped":35,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":35},{"fullName":5,"class":6},"Far Eastern Memorial Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group (Speaking Valve Intervention)","EXPERIMENTAL","Participants in the experimental group will receive early intervention using the Passy-Muir speaking valve while undergoing ventilator weaning. This intervention aims to improve communication ability, reduce depression levels, and enhance quality of life. The intervention will be implemented at four different time points (Baseline, Week 1, Week 2, Week 4), with structured assessments for effectiveness",[13],"Device: Passy-Muir Speaking Valve",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group (Standard Non-Verbal Communication)","ACTIVE_COMPARATOR","Participants in the control group will continue using standard non-verbal communication methods, such as lip-reading and gestures, during ventilator weaning. This group serves as a comparison to assess the effectiveness of early speaking valve intervention in tracheostomy patients.",[19],"Behavioral: Standard Non-Verbal Communication Methods",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Passy-Muir Speaking Valve","This intervention group receives early speaking valve intervention during ventilator weaning.",[9],[27],"Experimental Group",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BEHAVIORAL","Standard Non-Verbal Communication Methods","This control group continues using conventional non-verbal communication methods such as gestures and lip-reading.",[15],[34],"Control Group",null,[37],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"CHIA CHI HSU","CONTACT","+8860960606032","jiaqi92058@gmail.com",{"type":43,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100593373","early-speaking-valve-in-ventilator-weaning-effects-on-communication-depression-and-quality-of-life-100593373",false,"NCT07005596","Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life","Assessing the Impact of Early Tracheostomy Speaking Valve Intervention on Communication, Depression, and Quality of Life in Long-term Ventilator-dependent Patients During the Weaning Phase","Inclusion Criteria:\n\n* Age: ≥18 years old\n* Consciousness: Glasgow Coma Scale (GCS) score 13-15 (can voluntarily open eyes or respond when called, able to follow instructions to move)\n* Tracheostomy: Performed ≥24 hours, with no bleeding, pain, subcutaneous emphysema, pneumothorax, or infection\n* Ventilator Weaning: Trained according to the hospital's Respiratory Care Center standards, able to undergo spontaneous breathing training during the day\n* Ventilator Settings: FiO2 ≤40%\n* Vital Signs: Stable:\n* Heart rate 60-100 beats\u002Fmin\n* Respiratory rate 12-20 breaths\u002Fmin\n* Systolic blood pressure \\\u003C150 mmHg, diastolic blood pressure \\\u003C90 mmHg\n* Blood oxygen saturation 95-100%, no dyspnea complaints\n* Richmond Agitation-Sedation Scale (RASS) between -1 and +1\n* Language: Able to communicate in Mandarin, Taiwanese, or Hakka\n* Consent: Willing to participate in the study\n\nExclusion Criteria:\n\n* Recent surgery, anesthesia, or sedative use affecting consciousness\n* Severe unstable vital signs or inability to breathe normally\n* Upper airway obstruction or vocal cord paralysis\n* High dependence on ventilators or high-concentration oxygen therapy\n* History of depression or currently taking antidepressant medication","ALL","18 Years",{"count":54,"type":55},70,"ESTIMATED","INTERVENTIONAL",[58],"NA","This study evaluates the impact of early tracheostomy speaking valve intervention on communication ability, depression levels, and quality of life in ventilator-dependent patients during the weaning phase. Participants will be randomly assigned to either an experimental group using the Passy-Muir speaking valve or a control group employing standard non-verbal communication methods. Structured questionnaires will be used at multiple time points to assess changes in patient outcomes. The study aims to provide evidence supporting the use of speaking valves to enhance communication and emotional well-being in tracheostomy patients, potentially improving recovery and care strategies.",[61,62,63,64],"Respiratory Failure","Communication Disorders","Depression","Quality of Life",[66,67,68],"speaking valve","tracheostomy","communication","NOT_YET_RECRUITING","2025-06-04",{"date":72,"type":73},"2025-06-05","ACTUAL",{"date":75,"type":55},"2025-06-15",{"date":77,"type":55},"2027-12-31",{"name":5,"class":6}]