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

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.

Post-extubation BiPAP: same machine and pressures applied immediately after extubation and continued ≥ 48 h or until patient maintains SpO₂ ≥ 94 % for 24 h without BiPAP.

Standard care includes oxygen, nebulization, steroids, and surgical airway if necessary.

Eligibility (key points) Inclusion: age 18-80; scheduled thyroid/neck surgery; pre-op fixed cords at midline/paramedian or glottic gap ≤ 3 mm OR ≥ 2 high-risk factors (bilateral neck re-entry, tumor near both RLNs, bilateral C + L lymph-node dissection, severe OSA AHI ≥ 30, BMI ≥ 30).

Exclusion: emergency surgery, existing tracheostomy, ventilator dependence, mask intolerance, pregnancy, inability to consent.

Outcomes and Assessments

• Airway status monitored continuously POD 0-2, then daily to POD 7.
• ABG, pulse oximetry, and flexible laryngoscopy performed per protocol schedule.
• Adverse events graded by CTCAE v5.0; DSMB halting rule: ≥ 3 grade 3 airway failures in any arm.

Statistical Methods Intention-to-treat for primary endpoint. Log-binomial regression with center as random effect to estimate risk ratios for each main effect and their interaction. Kaplan-Meier curves for "tracheostomy-free survival." Interim analysis at 50 % information using O'Brien-Fleming alpha-spending.

Regulatory Status Devices (ResMed AirCurve 10 ST; Philips A40) are FDA-cleared class II ventilators (510(k)); IRB classified study as non-significant-risk device research exempt from IDE under 21 CFR 812.2(b).

Data Sharing De-identified individual participant data and statistical code will be shared upon reasonable request 6 months after final publication.

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.