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.
Age 18 - 80 years.
Scheduled for thyroidectomy or other neck surgery under general anesthesia.
Pre-operative flexible laryngoscopy showing fixed vocal cords at midline or paramedian position, or glottic gap ≤ 3 mm; OR
Planned bilateral central plus lateral neck dissection
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.
Factorial
Pre-operative BiPAP Training
DeviceSeven consecutive nights (≥ 4 h/night) of BiPAP use at home or on ward, pressure ladder EPAP 6→8 cmH₂O / IPAP 12→16 cmH₂O, recorded on SD card; devices: ResMed AirCurve 10 ST or Philips A40.
Post-extubation BiPAP Support
DeviceSame BiPAP device started immediately after tracheal extubation; EPAP 8 cmH₂O / IPAP 14 cmH₂O (or patient's final training setting) maintained ≥ 48 h, then weaned when SpO₂ ≥ 94 % off-BiPAP for 24 h.
Standard Peri-operative Care
Other interventionRoutine oxygen, nebulized steroids, airway monitoring; rescue re-intubation or tracheostomy per institutional protocol; no planned BiPAP unless crossover criteria met.
Composite "Airway Failure" (Tracheostomy OR Re-intubation)
Post-operative Day 0 through Day 7
Total BiPAP Usage Hours
Sum of hours recorded by device SD-card while patient is connected to BiPAP during the first 48 h after extubation.
Hypoxemic Episodes (SpO₂ < 90 % ≥ 3 min)
Number of discrete desaturation events captured by continuous pulse oximetry logs.
ICU Length of Stay
Hours from ICU admission to ICU discharge documented in EMR.
Voice Handicap Index-10 (VHI-10)
Patient-reported outcome; total score 0-40 (higher = worse voice handicap).
Click on the lead sponsor to view all of their trials.
Fujian Medical University
Lead sponsor
Fujian Medical University Union Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
