[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596247":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":49,"locations":57,"responsibleParty":70,"collaborators":35,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":35,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":107,"whyStopped":35,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Fujian Medical University","OTHER",[8,15,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Training + Post-op BiPAP","EXPERIMENTAL","Participants receive 7-day Pre-operative BiPAP Training and Post-extubation BiPAP Support for ≥ 48 h after surgery.",[13,14],"Device: Post-extubation BiPAP Support","Other: Standard Peri-operative Care",{"label":16,"type":10,"description":17,"interventionNames":18},"Training Only","Participants receive 7-day Pre-operative BiPAP Training. No routine BiPAP after extubation; peri-operative care otherwise standard.",[14],{"label":20,"type":10,"description":21,"interventionNames":22},"Post-op BiPAP Only","No pre-op training. BiPAP started immediately after extubation and continued ≥ 48 h.",[23,13],"Device: Pre-operative BiPAP Training",{"label":25,"type":26,"description":27,"interventionNames":28},"Standard Care","ACTIVE_COMPARATOR","No planned BiPAP. Airway managed with institutional standard care only.",[23,14],[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","Pre-operative BiPAP Training","Seven consecutive nights (≥ 4 h\u002Fnight) of BiPAP use at home or on ward, pressure ladder EPAP 6→8 cmH₂O \u002F IPAP 12→16 cmH₂O, recorded on SD card; devices: ResMed AirCurve 10 ST or Philips A40.",[20,25],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Post-extubation BiPAP Support","Same BiPAP device started immediately after tracheal extubation; EPAP 8 cmH₂O \u002F IPAP 14 cmH₂O (or patient's final training setting) maintained ≥ 48 h, then weaned when SpO₂ ≥ 94 % off-BiPAP for 24 h.",[20,9],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Standard Peri-operative Care","Routine oxygen, nebulized steroids, airway monitoring; rescue re-intubation or tracheostomy per institutional protocol; no planned BiPAP unless crossover criteria met.",[25,9,16],[45],{"name":46,"affiliation":47,"role":48},"Bo WANG, MD","Fujian Medical University Union Hospital","PRINCIPAL_INVESTIGATOR",[50,54],{"name":46,"role":51,"phone":52,"phoneExt":35,"email":53},"CONTACT","+8613959123550","wangbo@fjmu.edu.cn",{"name":55,"role":51,"phone":56,"phoneExt":35,"email":53},"WANG","13959123550",[58],{"facility":47,"status":35,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":35},"Fuzhou","FJ","350001","China","CN",{"type":65,"coordinates":66},"Point",[67,68],119.30611,26.06139,{"lat":68,"lon":67},{"type":48,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":47,"oldNameTitle":35,"oldOrganization":35},"Bo Wang,MD","Director & Head of Thyroid Surgery, Principal Investigator, Clinical Professor","100596247","peri-operative-bipap-to-prevent-tracheostomy-in-high-risk-bilateral-vocal-cord-paralysis-bvcp-100596247",false,"NCT07042971","Peri-operative BiPAP to Prevent Tracheostomy in High-Risk Bilateral Vocal-Cord Paralysis (BVCP)","A Multicenter, Randomized Controlled Trial of Pre-operative BiPAP Training and Post-extubation BiPAP Support to Reduce Peri-operative Tracheostomy or Re-intubation in Patients at High Risk for Bilateral Vocal-Cord Paralysis","BVCP-BiPAP","Inclusion Criteria:\n\n* Age 18 - 80 years.\n* Scheduled for thyroidectomy or other neck surgery under general anesthesia.\n* High risk of bilateral vocal-cord paralysis (BVCP) defined by at least ONE of:\n\n  * Pre-operative flexible laryngoscopy showing fixed vocal cords at midline or paramedian position, or glottic gap ≤ 3 mm; OR\n  * Presence of ≥ 2 high-risk factors:\n\n    * Planned bilateral central plus lateral neck dissection\n    * Re-operative bilateral neck surgery or dense scarring\n    * Tumor involving both recurrent laryngeal nerves or crico-arytenoid joints\n    * Severe obstructive sleep apnea (AHI ≥ 30 events\u002Fhour)\n    * Body-mass index (BMI) ≥ 30 kg\u002Fm²\n* Able to tolerate and give informed consent for BiPAP mask use.\n\nExclusion Criteria:\n\n* Emergency surgery or need for immediate tracheostomy.\n* Existing tracheostomy or home ventilator dependence.\n* Inability to protect airway (e.g., Glasgow Coma Scale \\\u003C 13).\n* Craniofacial anomaly or skin condition precluding mask seal.\n* Pregnancy or breastfeeding.\n* Participation in another interventional trial that could interfere with study endpoints.","ALL","18 Years","80 Years",{"count":85,"type":86},204,"ESTIMATED","INTERVENTIONAL",[89],"NA","Why: After thyroid or neck surgery, some patients can lose movement of both vocal cords (bilateral vocal-cord paralysis, BVCP). This can make breathing difficult and often leads to an emergency or preventive tracheostomy (\"wind-pipe\") surgery.\n\nWhat: This study will test two simple ways to avoid a tracheostomy:\n\nPre-operative BiPAP sleep training - patients practice sleeping with a non-invasive BiPAP breathing machine for seven nights before surgery so they become comfortable with the mask and pressures.\n\nImmediate post-extubation BiPAP support - the same BiPAP machine is started as soon as the breathing tube is removed in the operating room or recovery area.\n\nHow: Adults (18-80 years) who already have, or are at high risk of getting, BVCP will be randomly assigned to one of four groups in a 2 × 2 design:\n\n• Group 1: training + post-op BiPAP • Group 2: training only • Group 3: post-op BiPAP only • Group 4: standard care (no planned BiPAP).\n\nMain goal: To find out whether either or both BiPAP strategies reduce the need for tracheostomy or re-intubation during the first 7 days after surgery.\n\nWhat participants do: Eligible patients will undergo routine surgery plus the assigned BiPAP plan. Breathing events, comfort, hospital stay, and voice quality will be recorded up to 6 months.\n\nPotential benefit\u002Frisk: BiPAP is non-invasive and already FDA-cleared for home and hospital use, but some people may feel mask discomfort or air leaks. Trained staff will adjust settings and stop BiPAP if serious problems occur.",[92,93,94,95],"Vocal Cord Paralysis, Bilateral","Airway Obstruction, Postoperative","Thyroid Neoplasms","Sleep Apnea, Obstructive",[97,98,99,100,101,102,103,104,105,106],"BiPAP","Non-invasive Ventilation","Continuous Positive Airway Pressure","Peri-operative Airway Management","Tracheostomy Avoidance","Thyroidectomy","Neck Surgery","Glottic Stenosis","Pre-operative Sleep Training","Voice Handicap Index","NOT_YET_RECRUITING","2025-06-27",{"date":110,"type":111},"2025-06-29","ACTUAL",{"date":113,"type":86},"2025-07-01",{"date":115,"type":86},"2029-12-31",{"name":5,"class":6},1]