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

NANot yet recruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2028

Study Completion Date

December 31, 2029

Conditions
Vocal Cord Paralysis, BilateralAirway Obstruction, PostoperativeThyroid NeoplasmsSleep Apnea, Obstructive
Interventions
DEVICE

Pre-operative BiPAP Training

Seven 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.

DEVICE

Post-extubation BiPAP Support

Same 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.

OTHER

Standard Peri-operative Care

Routine oxygen, nebulized steroids, airway monitoring; rescue re-intubation or tracheostomy per institutional protocol; no planned BiPAP unless crossover criteria met.

Trial Locations (1)

350001

Fujian Medical University Union Hospital, Fuzhou

All Listed Sponsors
lead

Fujian Medical University

OTHER