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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Composite "Airway Failure" (Tracheostomy OR Re-intubation)
研究概览
简要总结
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.
What: This study will test two simple ways to avoid a tracheostomy:
Pre-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.
Immediate 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.
How: 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:
• Group 1: training + post-op BiPAP • Group 2: training only • Group 3: post-op BiPAP only • Group 4: standard care (no planned BiPAP).
Main 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.
What 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.
Potential benefit/risk: 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.
详细描述
Background and Rationale Bilateral vocal-cord paralysis (BVCP) after thyroid and neck procedures poses an immediate risk of airway obstruction. Historical management favors prophylactic or rescue tracheostomy; however, tracheostomy carries morbidity, cost, and long-term stigma. Case series suggest that non-invasive ventilation (NIV) using BiPAP can stent the glottic opening while providing ventilatory support, but no prospective randomized data exist.
Objectives Primary: Compare the 7-day composite rate of (a) tracheostomy or (b) re-intubation among patients managed with (i) pre-operative BiPAP training, (ii) immediate post-extubation BiPAP, both, or neither.
Secondary: BiPAP usage hours, hypoxemic events, ICU/hospital length of stay, Voice Handicap Index-10 (VHI-10) and Eating Assessment Tool-10 (EAT-10) scores, normalized glottic area (NGA %) at 6 months, cost.
Study Design Multicenter, open-label, factorial (2 × 2) randomized controlled trial. Randomization (block size = 4) stratified by center. Total planned enrollment: 204 (to allow for 10 % attrition), yielding ~46 evaluable participants per arm.
Interventions Pre-operative BiPAP training: nightly ≥ 4 h for 7 consecutive nights, pressure ladder EPAP 6 → 8 cmH₂O / IPAP 12 → 16 cmH₂O, recorded on SD-card.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Open-label; blinding not feasible because BiPAP mask/pressures are apparent. Primary endpoint (tracheostomy or re-intubation) is objective.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 years.
- •Scheduled for thyroidectomy or other neck surgery under general anesthesia.
- •High risk of bilateral vocal-cord paralysis (BVCP) defined by at least ONE of:
- •Pre-operative flexible laryngoscopy showing fixed vocal cords at midline or paramedian position, or glottic gap ≤ 3 mm; OR
- •Presence of ≥ 2 high-risk factors:
- •Planned bilateral central plus lateral neck dissection
- •Re-operative bilateral neck surgery or dense scarring
- •Tumor involving both recurrent laryngeal nerves or crico-arytenoid joints
- •Severe obstructive sleep apnea (AHI ≥ 30 events/hour)
- •Body-mass index (BMI) ≥ 30 kg/m²
- •Able to tolerate and give informed consent for BiPAP mask use.
排除标准
- •Emergency surgery or need for immediate tracheostomy.
- •Existing tracheostomy or home ventilator dependence.
- •Inability to protect airway (e.g., Glasgow Coma Scale < 13).
- •Craniofacial anomaly or skin condition precluding mask seal.
- •Pregnancy or breastfeeding.
- •Participation in another interventional trial that could interfere with study endpoints.
研究组 & 干预措施
Training + Post-op BiPAP
Participants receive 7-day Pre-operative BiPAP Training and Post-extubation BiPAP Support for ≥ 48 h after surgery.
干预措施: Standard Peri-operative Care (Other)
Training + Post-op BiPAP
Participants receive 7-day Pre-operative BiPAP Training and Post-extubation BiPAP Support for ≥ 48 h after surgery.
干预措施: Post-extubation BiPAP Support (Device)
Training Only
Participants receive 7-day Pre-operative BiPAP Training. No routine BiPAP after extubation; peri-operative care otherwise standard.
干预措施: Standard Peri-operative Care (Other)
Post-op BiPAP Only
No pre-op training. BiPAP started immediately after extubation and continued ≥ 48 h.
干预措施: Pre-operative BiPAP Training (Device)
Post-op BiPAP Only
No pre-op training. BiPAP started immediately after extubation and continued ≥ 48 h.
干预措施: Post-extubation BiPAP Support (Device)
Standard Care
No planned BiPAP. Airway managed with institutional standard care only.
干预措施: Pre-operative BiPAP Training (Device)
Standard Care
No planned BiPAP. Airway managed with institutional standard care only.
干预措施: Standard Peri-operative Care (Other)
结局指标
主要结局
Composite "Airway Failure" (Tracheostomy OR Re-intubation)
时间窗: The first occurrence of (a) surgical tracheostomy or (b) endotracheal re-intubation for respiratory distress within 7 days after extubation. Event status adjudicated by an independent investigator using pre-defined criteria.
Post-operative Day 0 through Day 7
次要结局
- Total BiPAP Usage Hours(Post-op Day 0 to Day 2 (48 hours))
- Hypoxemic Episodes (SpO₂ < 90 % ≥ 3 min)(Post-op Day 0 to Day 2)
- ICU Length of Stay(Surgery end → ICU discharge (up to 7 days))
- Voice Handicap Index-10 (VHI-10)(6 months (±14 days) post-op)
- Normalized Glottic Area (NGA %)(Baseline pre-op and 6 months post-op)
研究者
Bo Wang,MD
Director & Head of Thyroid Surgery, Principal Investigator, Clinical Professor
Fujian Medical University Union Hospital