Peri-operative BiPAP to Prevent Tracheostomy in High-Risk Bilateral Vocal-Cord Paralysis (BVCP)

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.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.