[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vocal-cord-paralysis-bilateral\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vocal-cord-paralysis-bilateral":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"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":21,"type":22},204,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Vocal Cord Paralysis, Bilateral","Airway Obstruction, Postoperative","Thyroid Neoplasms","Sleep Apnea, Obstructive",[33,34,35,36,37,38,39,40,41,42],"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":46,"type":47},"2025-06-29","ACTUAL",{"date":49,"type":22},"2025-07-01",{"date":51,"type":22},"2029-12-31",{"name":53,"class":54},"Fujian Medical University","OTHER"]